| Job Title | Location |
|---|---|
| Senior Electrical Engineer, cGMP Facilities
This is an exciting opportunity as a Senior Electrical Engineer within an expanding Biologics Manufacturing Organization. You will be responsible for providing technical support to the manufacturing, laboratory, and logistics buildings, focusing on troubleshooting, modifications, and improvements related to electrical systems, back-up power, sustainable projects, and management systems. Your roles and responsibilities will also include: Key Responsibilities:
Desired Skills:
About the Company: The position is within a top BioPharma company that is rapidly growing its development pipeline, commercial product line and manufacturing operations. This is an outstanding opportunity work in a major award winning Maryland based state-of-the-art large scale commercial biologics manufacturing facility. This site is a worldwide industry leader in mammalian cell culture manufacturing and has a promising pipeline of incoming Cell & Gene Therapies, mAb/recombinant protein and ADC therapeutic products. |
Frederick, MD |
| Sr Scientist, Protein and Carbohydrate Chemistry
This is an exciting opportunity within an innovative food and nutritional products company. You will work with plant proteins and carbohydrates to assess and improve function in order to create and develop novel plant-based products. These products will include functional foods, medical foods and highly nutritional food and beverages. Your overall roles and responsibilities will include: * Identifying, isolating, characterizing and modifying proteins and carbohydrates to improve functionality in plant-based foods and beverages. * Leading experiments and process development efforts involving protein and carbohydrate biochemistry, structure, and biotransformation. * Collaborating with cross-functional teams on R&D projects and product commercialization efforts related to protein and carbohydrate chemistry. * Promoting innovation by tracking new developments in relevant scientific fields in order to identify and pursue strategic product development opportunities. * Training research assistants, students, and other related staff in research techniques and analysis. Desired Skills: * M.S. or Ph.D. in Biochemistry, Protein Chemistry, Chemistry, Molecular Biology, Biology or related life science field. * Experience characterizing carbohydrates using enzymatic assays, HPLC, GC, size exclusion chromatography, and other methods of chromatography. * Expertise in protein characterization, including enzymatic and instrumental methods. * Analytical method development expertise characterizing proteins or carbohydrates utilizing gel electrophoresis, SDS-PAGE, HPLC, Western Blotting, Enzyme Activity Assays, and Protein Isolation and Purification. * Experience working with food proteins, grain proteins, lipids, vitamins, and other nutritional food components a plus. * The ideal candidate will have patents and publications demonstrating an ability to innovate. * thirty About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Scientist/Sr Scientist, Protein Chemistry and Fermentation Sciences
This is an exciting opportunity within an innovative food and nutritional products company. You will work with plant proteins and carbohydrates to assess and improve function in order to create and develop novel plant-based products. These products will include functional foods, medical foods and highly nutritional food and beverages. Your overall roles and responsibilities will include: * Identifying, isolating, characterizing and modifying proteins and carbohydrates to improve functionality in plant-based foods and beverages. * Designing and leading experiments and process development efforts involving microbial fermentation and biotransformation. * Leading experiments and process development efforts involving protein and carbohydrate biochemistry, structure and biotransformation. * Collaborating with cross-functional teams on R&D projects and product commercialization efforts relating to protein and carbohydrate chemistry. * Promoting innovation by tracking new developments in relevant scientific fields in order to identify and pursue strategic product development opportunities. * Train research assistants, students, and other related staff in research techniques and analysis. Desired Skills: * M.S. or Ph.D. in Biochemistry, Protein Chemistry, Chemistry, Molecular Biology, Biology or related life science field. * Expertise in protein characterization, including enzymatic and instrumental methods. * Expertise performing microbial, bacterial or yeast fermentation processes. * Analytical method development expertise characterizing proteins or carbohydrates utilizing gel electrophoresis, SDS-PAGE, HPLC, Western Blotting, Enzyme Activity Assays, and Protein Isolation and Purification. * Experience working with food proteins, lipids, vitamins, and other nutritional food components a plus. * The ideal candidate will have patents and publications demonstrating an ability to innovate. About the Company: This position is within a Buffalo Area natural products and nutritional foods spinoff company backed by a major CPG, Dairy and Nutritional Products Manufacturer. It is an incredible opportunity to get on board within an ultra-innovative, fast paced and friendly entrepreneurial environment with an exciting portfolio of new product launches. |
Buffalo, NY |
| Business Unit Manager
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About the Company: This is an exciting new position within a top-tier Midwest based Food & Nutritional Products Company with a wide variety of product types including innovative powders and low acid aseptic beverages targeting consumers who seek healthier alternatives. The company is experiencing rapid company growth and expansion. |
Zionsville, IN |
| Manufacturing Engineer
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About the Company: This is an exciting new position within a top-tier Midwest based Food & Nutritional Products Company with a wide variety of product types including innovative powders and low acid aseptic beverages targeting consumers who seek healthier alternatives. The company is experiencing rapid company growth and expansion. |
Zionsville, IN |
| Production Supervisor-Liquids & Aseptics
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About the Company: This is an exciting new position within a top-tier Midwest based Food & Nutritional Products Company with a wide variety of product types including innovative powders and low acid aseptic beverages targeting consumers who seek healthier alternatives. The company is experiencing rapid company growth and expansion. |
Zionsville, IN |
| Engineering and Maintenance Manager, Complex Food Manufacturing
This is a stellar opportunity within an established, thriving, and growing Midwest based complex foods market leader. You will be responsible for managing the maintenance services to enable operations and other functions to meet or exceed business expectations. Your responsibilities will also include: * Developing and communicating a clear vision for a fully integrated Maintenance team aligned with company goals. * Providing leadership through the identification and introduction of innovative solutions. * Driving continuous improvement, exploring industry trends, developing strategies, and driving leading edge technology and innovation. * Establishing capital spending strategies to effectively identify and invest in company assets. * Understanding the procurement polices and working cross functionally to ensure compliance with internal policies and procedures. * Developing staff and building a high-performance team by setting expectations, ensuring ongoing coaching/mentoring, and assessing employee performance. * Leading projects and teams supporting large scale company initiatives. * Building technical competencies within the maintenance team, identifying, and selecting maintenance talent to support developing technology, and providing opportunities for knowledge acquisition and skills transfer within the team. Desired Skills: * Bachelor's degree in engineering or a related field. MBA or other advanced degree preferred. * 7-10+ years in Plant Maintenance roles supporting manufacturing and/or utility operations. * Experience managing or leading maintenance teams including reliability centered programs. * Experience managing people in a dynamic environment and a track record of developing people. * Experience within a highly regulated environment. * Proven decision-making skills, strong troubleshooting, planning, prioritization, multi-tasking, and delegation skills. * Ability to communicate issues, goals, and objectives to facilitate an effective team-oriented environment. * Demonstrated ability to work with a range of technically and culturally diverse people, delivering value added business results that meet high quality * Significant experience in powder and liquid processing and packaging of food products, preferably within a highly regulated food or pharmaceutical environment. * Knowledge of engineering and maintenance concepts and industry technology. * Understanding of manufacturing processes and mastery knowledge of utility sustainability, power supply and demand. * thirty About the Company: This is an exciting new position within a top-tier Midwest based Food & Nutritional Products Company with a wide variety of product types including innovative powders and low acid aseptic beverages targeting consumers who seek healthier alternatives. The company is experiencing rapid company growth and expansion. |
Zionsville, IN |
| Autonomous Driving, Senior Engineer, SW Architect & Platform Developer
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About the Company: Expatriate Benefits Package: * Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits. * Company paid apartment in South Korea. * International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within a Global role and gain valuable international experience.
|
San Francisco, CA |
| Sr. Manager, Global Social Media & Digital Communications, Expat in South Korea
This is an exciting new Global Expat opportunity responsible for leading multifaceted Social Media Channel and Digital Communications within the within the Global Headquarters of a Major Global Corporation in South Korea. You will be charged with planning and managing the company's Global Social Channels and Digital Content aligned with its brand and products. You will also be responsible for managing collaboration opportunities with promising online influencers and creators. Your responsibilities will also include: * Executing new tech-based initiatives boldly and agilely, leveraging deep understanding of innovative digital techniques, media trends and data solutions to generate buzz around the company brand. * Planning and Managing the company's Social Media Channels and Digital Communications across Global regions including APAC, the Americas, Europe, Africa and Middle East. * Ensuring social channels and digital content is aligned consistency with its Global brand and products. * Planning and creating social content based on the discovery of new topics and trends. * Executing digital media and ad performance/social monitoring strategies. * Building and managing relationship with Global digital agencies. * Discovering and utilizing AI based marketing tools and technologies as well as integrating AI-based technology into digital marketing strategies, content planning and content production, * Identifying and collaborating with Global content creators as well as planning new collaboration campaigns with online digital creators, influencers and editors. Desired Skills: * 8+ years of industry experience in digital marketing, advertising and communications within a top tier Global brand or Global advertising agency. * Bachelor's or Master's degree in Communications, Marketing, Business Administration, Communication Design, Fine Arts, Visual Arts, Graphic Design or related field. * Proven experience overseeing Social Channels and Social Media workflows, processes and digital campaign management for a major Global brand. * Strong eye for detail and the ability to maintain brand consistency across various platforms and materials * Proficient in using Social Channel or Social Media management software, apps and tools such as Hootsuite, Sprout Social, Buffer, Agorapulse or Sendible. * Knowledge, understanding and enthusiasm for the automotive and mobility industries. * Excellent communication and collaboration skills, with the ability to work effectively with Global cross-functional teams. * Passion for staying up-to-date with the latest Social Media, Digital Marketing, AI Marketing trends, marketing strategies, and brand best practices. About the Company: Expatriate Benefits Package: * Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits. * Company paid apartment in South Korea. * International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within a Global role and gain valuable international experience.
|
Los Angeles, CA |
| Sr. Manager, Marketing, Brand Image Management, Expat in South Korea
This is an exciting new Expat opportunity responsible for leading Global Brand Management activities within the Global Headquarters of a Major Global Corporation in South Korea. You will be charged with securing the consistency of the company's global brand image and producing various content to introduce and communicate the global brand vision to customers. Additionally, you will be responsible for developing and implementing brand image strategies and guidelines, as well as creating innovative brand communication assets. Your responsibilities will also include: * Manage and oversee the corporate brand image to be consistent across Global regions including APAC, the Americas, Europe, Africa and Middle East. * Generate creative content to communicate the company?s vision to global customers. * Lead Brand Image Management functions including the monitoring of the global brand image, developing a brand image training program and conducting global brand image training programs. * Locating brand difficulties across regions and updating corporate brand image guidelines. * Providing design feedback on marketing materials created globally. * Leading Brand Communication functions including the development of brand image guidelines and style guides. * Developing creative content including logos, ads and marketing materials. Desired Skills: * 8+ years of industry experience in graphic design, advertising, or brand communications within a top tier Global brand or advertising agency. * Bachelor's or Master's degree in Graphic Design, Communication Design, Fine Arts, Visual Arts, Marketing or related field. * Proven track record of developing and implementing successful style guides, brand image and communication strategies for major global brands. * Strong eye for detail and the ability to maintain brand governance and consistency across various platforms and materials * Proficient in using design software, such as Adobe Creative Suite (Photoshop, Illustrator, InDesign), Microsoft Office (PowerPoint, Excel), and other presentation tools. * Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams * Passion for staying up-to-date with the latest design trends, marketing strategies, and brand best practices About the Company: Expatriate Benefits Package: * Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits. * Company paid apartment in South Korea. * International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within a Global role and gain valuable international experience.
|
Los Angeles, CA |
| Sr. Manager, Global Learning Development, Expat in South Korea
This is a new Expat opportunity responsible for driving the design, implementation, and evaluation of impactful talent development initiatives based within the Global Headquarters of a Major Global Corporation in South Korea. The organization is committed to developing and enriching its leadership pipeline to drive continuous improvement and sustainability. In this strategic role, you will be responsible for accelerating the leadership, skills, and impact of high-potential employees and global leaders to align with the company's mission, culture, and customer needs. Additionally, you will be charged with overseeing the following key activities: * Design, develop and execute comprehensive talent and leadership development programs, including coaching, mentoring, and the cultivation of leadership, business acumen, and management capabilities. * Create consistent methodologies for programs to ensure high-quality and impactful learning experiences. * Partner with HR and regional talent leads to identify and secure nominations for high-potential employees to participate in talent development programs. * Collaborate with subject matter experts to gather content and deliver engaging, effective learning solutions. * Establish relationships with external vendors and learning providers to optimize Hyundai's learning initiatives. * Monitor industry trends and best practices in learning development and recommend innovative approaches to enhance the learning experience and drive organizational success. * Coordinate customized executive development programs, such as targeted coaching. * Apply talent data and insights to have action-oriented conversations with stakeholders, informing strategies for the retention and development of key talent. * Collaborate with leadership to design assessment tools and measure the impact of talent development programs. * Analyze HR data to produce insights that can inform future talent strategy and initiatives. * Lead Global Engagement through the delivery of in-house lectures and facilitation on corporate content to support organizational learning and development. * Lead and manage direct communication channels with overseas HR and talent development managers to align global learning initiatives. Desired Skills: * BS Degree in Business Administration, Marketing, Advertising, Human Resources, Communications, Management, Economics, Psychology or related field. MBA or Masters Degree a plus. * 8+ years of Talent Development, Talent Management or Learning Development related experience within a Global enterprise company, preferably within the Automotive, Technology, Consumer Products or related industries. * Human Resources, Training or Learning Development Certifications such as SPHR, CPLP, CTDP or CPTD preferred. * Prior experience leading the design and delivery of learning solutions for diverse groups of learners, particularly executive leaders and high-potential employees * Exceptional knowledge of learning theories, instructional design methodologies, psychometric tools, and adult learning principles * Excellent verbal and written communication skills, with the ability to present effectively across various forums and to diverse audiences. * Experience managing learning programs and projects, including budgeting and resource allocation. Demonstrated expertise in identifying, assessing, and managing external vendor partners. * Exceptional facilitation skills and experience leading and managing large-scale, complex learning program design and delivery projects with various stakeholders globally. About the Company: Expatriate Benefits Package: * Competitive Base Salary, Target Bonus, Korean retirement allowance and South Korea healthcare benefits. * Company paid apartment in South Korea. * International school tuition paid for K-12 grade children at a top International School such as Chadwick International, Seoul Foreign School (Ken Jennings is an alumnus), Korea International School or Yongsan International School. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within a Global role and gain valuable international experience.
|
Los Angeles, CA |
| MSAT Manager, Cell Therapies Manufacturing
This is an exciting new opportunity responsible for leading Manufacturing Sciences & Technology (MSAT) and External Manufacturing activities for novel cell therapy manufacturing and process development advancements. Your roles and responsibility will include: * Leading MSAT projects related to cell therapy manufacturing process improvements and deviation resolutions. * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to upstream cell culture related process improvement, process validation, process change control, deviation investigation and process characterization activities. * Supporting tech transfer and manufacturing activities at external Contract Manufacturing sites. * Developing and implementing manufacturing strategies for resolving complex issues and deviation resolutions for manufacturing investigations and process improvements. * Providing subject matter expertise relating to upstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Serving as a technical/scientific Subject Matter Expert for aseptic manufacturing and cell culture activities ranging from production in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities. * Training downstream staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings. Desired Skills: * BS or MS in Biochemical Engineering, Microbiology, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, aseptic manufacturing and cell culture activities in shake flasks, T-flasks, hyper flasks, cell stacks and bioreactors. * Expertise is Process Validation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV). About the Company: This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.
|
Philadelphia, PA |
| Sr. Manager, Global Brand Heritage - Expat in Seoul, South Korea
This is an exceptional expatriate opportunity to lead the Brand Heritage strategies within the Global Headquarters of a major Automotive Company in Seoul, South Korea. You will play a pivotal role in enhancing the global brand by fostering a deep sense of pride grounded in the company's rich legacy, tradition, and 80-year history. Your responsibilities will include:
Desired Skills:
*** Please Note - This is a full-time Expat Opportunity Based in South Korea. You must be open to living and working in South Korea. A company paid apartment and International School tuition is provided. ** |
Los Angeles, CA |
| Sr. Project Engineer, Complex Nutritional Foods Manufacturing
This is a stellar opportunity within an established, thriving and growing Midwest based complex food production company! You will be responsible for leading plant-wide processing and packaging related engineering projects for the successful manufacturing of brand name complex food products. Your hands on responsibilities will also include: * Overseeing projects including new construction, equipment upgrades, equipment installations, and entire manufacturing line installations. * Leading $10-20 M capital projects and process improvements involving food production and packaging equipment including clean rooms, blending systems, mixing tanks, steam injectors, spray dryers, liquid processing tanks, conveyors, and palletizers. * Leading and designing project budgets, schedules, construction, commissioning, and project take-over activities. * Managing project costs, cost proposals, project budgets, and capital budgets. * Leading and managing engineers, contractors, and external vendors. * Providing cGMP and GMP documentation activities, writing SOPs, and developing PFD and P&ID, equipment and piping layout, and process and equipment specifications for bids. Desired Skills: * BS or MS degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering or related Engineering field. * 5+ years of Engineering experience working within an FDA regulated facility such as for food and beverage, dairy, nutritional products, infant formula or pharmaceutical manufacturing. * Exceptional Project Management, Project Leadership, Process Improvement, and Capital Project Management experience. * Capital Project Engineering experience working on clean rooms, blending systems, mixing tanks, steam injectors, spray dryers, liquid processing tanks, conveyors, and/or palletizers. * Expertise in microbiology or projects relating to the containment of microbial pathogens a plus. * Process Improvement experience implementing Six Sigma methodologies involving Process Mapping, CTQ, Root Cause Analysis, Control Charts and Statistical Process Control (SPC). Six Sigma Green Belt or Six Sigma Black Belt a plus. * Expertise working within cGMP, FDA, HACCP & OSHA compliance and providing appropriate engineering documentation & SOPs. * Lean Six Sigma or PMP Certifications a plus. * thirty About the Company: This is an exciting new position within a top-tier Food & Consumer Products Company experiencing rapid company growth and international expansion. |
Grand Rapids, MI |
| Sr Manager, Project Management & Tech Transfer, Expat in South Korea
This is an exciting opportunity to lead Project Management and Tech Transfer related manufacturing activities for biologics manufacturing. This is a once-in-a-lifetime expatriate leadership opportunity within the World?s Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with the following activities: * Managing Project schedules, timelines, project scopes and business processes with clients, including project master schedule generation and updates. * Serving as a primary point of contact for communications between external Clients and internal teams to facilitate tech transfer projects. * Managing regular weekly and monthly client communications relating to forecasting, manufacturing schedules, change controls, deviations, risk assessments and mitigations. * Overseeing Project Change Request management, including generating and managing Scope of Work (SoW), confirming contract scope and alignment, and managing change orders for additional scope of work. * Managing Core Teams and cross-functional client communications for critical issues, including arranging and leading regular/ad-hoc meetings with associated teams. * Providing technical leadership and subject matter expertise relating to deviations, change controls, process optimization, and technical troubleshooting. * Working cross functionally with Process Development, Manufacturing, Quality and Regulatory departments relating to process improvements, process change controls and deviation investigations. Desired Skills: * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Project Management leadership experience managing tech transfer processes between client companies and CMOs. * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Biologics manufacturing expertise manufacturing large molecule biologics including monoclonal antibodies, Antibody Drug Conjugates, fusion proteins or bispecific antibodies. Experience working within a biologics CMO/CDMO a plus. * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Quality, Regulatory and Engineering Services departments. * Expertise involving QbD (Quality by Design), Lean Manufacturing and Six Sigma methodologies. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Sr. Manager, Information Technology Quality Assurance, Biologics Manufacturing - Expat Opportunity in South Korea
This is an exciting opportunity to lead the newly established IT QA group within a cutting-edge biologics manufacturing facility. As part of a leading Global Contract Manufacturing Organization (CMO), you will be responsible for overseeing the digitalization efforts and ensuring consistency with GMP and site Quality policies. You will be charged with overseeing the following activities:
Desired Skills:
About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
San Francisco, CA |
| Senior Manager, QC Biochemistry and Analytical Method Transfer - Expat in Songdo, South Korea
This is an exciting leadership opportunity overseeing the Quality Control Biochemistry team and Analytical Method Transfer group within a leading Contract Manufacturing Organization (CMO). This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include: * Providing strategic direction and leadership for the QC Biochemistry team responsible for performing and reviewing chemistry/biochemistry product tests, managing test schedules for drug substance/drug product plants, and stability studies. * Overseeing Analytical Method Transfer including analytical method development, optimization, transfer, validation, and lifecycle management activities. * Leading analytical method gap assessments, authoring method implementation master plans (MIMPs), and executing phase-appropriate implementation of analytical test methods for release/stability testing. * Ensuring the establishment and monitoring of assay performance criteria. * Managing platform methods in collaboration with CDMO partners. * Overseeing authoring of chromatography methods, protocols, and reports. * Leading execution of method transfer, pre-validation, and validation activities. * Overseeing laboratory control activities, including audit/inspection response and client communication. * Supporting deviation/CAPA/change control investigations, NCRs, OOTs, and stability protocol reviews. * Ensuring PAI readiness, supporting BLA/CMC filings and hosting FDA/EMEA audits & inspections. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific field. * 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large-scale or commercial biologics manufacturing environment. * Strong leadership and organizational skills for managing cross-functional QC teams. * Expertise in analytical chemistry techniques (HPLC/UPLC, ICE, CE, UV) and biochemistry analyses (ELISA, qPCR, cell-based assays). * Experience in analytical method development, optimization, qualification, and validation for biologics. * Proficiency in stability testing, reference standards management, and assay performance monitoring. * Knowledge of GMP requirements and industry standards related to analytical methods and QC operations. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| AAV Development Group Leader
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About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Lead Internal Quality Assurance Auditor, Expat in Songdo, South Korea
This is an exciting opportunity to direct, manage, plan, and perform internal audits including operational and compliance audits. This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include: * Lead Audits: Serve as the lead auditor for internal audits, ensuring timely escalation of critical findings. * Report Findings: Provide reports of audit findings, analysis and recommendation to Quality Senior Management in a timely manner in order to strengthen and improve internal control, equity, and operational performance. * Stakeholder Engagement: Collaborate with auditees to enhance internal controls and operational efficiency. * Audit Schedule Management: Maintain and update the annual internal audit schedules. * Report Preparation: Prepare detailed audit reports and review audit responses. * Continuous Improvement: Support management in continuous improvement initiatives. * Regulatory Monitoring: Keep abreast of regulatory regulations and present updates to GMP Auditing to ensure departmental compliance. * Inspection Support: Provide support during health authority inspections. * Auditor Training: Conduct auditor training and certification programs. * Electronic Systems: Utilize and update audit-related documents in the electronic inspection system. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific field. * 10+ years of Quality and GMP experience in the BioPharmaceutical industry, with at least 3 years of GMP auditing experience. * Knowledge of Data Integrity investigation and Data Flow and Data Criticality across the product lifecycle. * Knowledge of Data Flow and Data Criticality of regulated activities across product lifecycle. * Comprehensive understanding of ICH, FDA, and EMA GMP requirements, regulatory guidelines, and industry standards. * Expertise in Quality Management Systems, including Electronic Data Management Systems (EDMS), Electronic Quality Management Systems (EQMS), and Laboratory Information Management Systems (LIMS). * Excellent communication and leadership skills. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Validation Engineering Manager, ADC Manufacturing, Expat in Songdo, South Korea
This is a stellar opportunity responsible for leading ADC Validation Engineering processes and serving as a SME for ADC manufacturing. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Serving as a SME for Antibody Drug Conjugate equipment validation, facility validation and cleaning processes. * Serving as a SME for Isolator equipment qualification and containment performance assessment and verification. * Generating and maintaining Validation Master Plans and Revalidation plans. * Authoring and generating essential validation documents including validation protocols, validation reports and test plans to support facility startup and tech transfer of ADC products. * Updating and generating validation policies and procedures to incorporate ADC validation practices into the site validation program. * Implementing the site Antibody Drug Conjugate containment verification program including training of personnel, revalidation and certification processes. * Supporting Global Regulatory Agency inspections and audits. Desired Skills: * 8+ years working experience with ADC biopharmaceuticals, including manufacturing process development. * BS or MS in Biochemistry, Biology, Chemistry, Chemical Engineering, Mechanical Engineering or related Life Sciences or Engineering field. * Solid understanding of ADC manufacturing processes and equipment and risk assessments. * Expertise in validation for ADC manufacturing including setting up containment performance targets, verification of containment performance, cleaning requirements for ADC manufacturing and isolator qualification processes. Understanding of ADC regulatory requirements and technical standards such as ISPE guideline for Assessing the Particulate Containment Performance of Pharmaceutical Equipment. * Familiarity with FDA and cGMPs for ADC manufacturing. * thirty About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Director/Sr Director, Quality Assurance, Biologics Manufacturing, Expat in South Korea
This is an exciting US expatriate executive leadership position responsible for overseeing strategic Quality operations within a best-in-class Asia based Global Contract Manufacturing Organization (CMO). This position is responsible for overseeing multiple Quality Center operations within the World's Largest biologics CMO with commercial mammalian cell culture Drug Substance manufacturing capacity, Antibody Drug Conjugate manufacturing as well as major Drug Product manufacturing operations. Your roles and responsibility will include: * Defining, developing and overseeing company Quality functions and roadmaps including Quality Strategy & Implementation, Compliance and Risk Management Strategy, Client & Regulatory Agencies Relationships Management, and Resources & Quality Innovation Management. * Overseeing Quality Strategy & Implementation within a multi-plant large scale mammalian cell culture manufacturing environment across multiple commercial biologics manufacturing with commercial drug substance and drug product manufacturing capacity. * Overseeing and managing the Quality organization's budget, ensuring all budgets meet company targets. * Communicating, deploying and executing the company?s Quality roadmap across the organization. * Ensuring the adherence to the company Compliance Risk Management program which manages risks associated with deviations from regulatory requirements. * Providing input on issues, opportunities, risks, and risk management to clients. * Supporting Regulatory submissions and inspections across sites, advising on best regulatory path to accelerate approval. * Leading, developing, and executing quality and regulatory initiatives in compliance with company procedures and ethics. * Supporting Innovation strategies in line with quality processes, including reporting of Performance of a Lean culture. * Ensuring necessary resources are available to support the execution of quality, regulatory, and compliance objectives. Desired Skills: * BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field. * 20+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large scale or commercial biologics manufacturing environment. * Quality Assurance leadership experiences overseeing the manufacturing of complex biologic molecules including monoclonal antibodies, ADC's, Bispecific Antibodies or Fusion Proteins. * Exceptional strategic team leadership and functional Quality organizational leadership experience. * Strong Scientific and Engineering expertise leading Quality Operations for the generation of monoclonal antibodies, recombinant protein therapeutic products or commercial mRNA vaccines. * Experience leading multiple Quality operations, organizational strategies, roadmaps and functions for large scale organizations. * Expertise leading Compliance initiatives within a large scale organization. * In depth understanding of life science operations and business practices, throughout product life cycles, for the development of drugs and medical devices. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Gaithersburg, MD |
| Group Leader, CMC Regulatory Affairs, Biologics Manufacturing
This is an incredible foreign expatriate position charged with leading a 10-15 person CMC Regulatory Affairs team within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine, complex large molecules and ADC manufacturing capabilities. You will be responsible for managing and supervising regulatory strategies and associated filings including clients? filing support for Drug Substances and Drug Products. You will also be responsible for performing the following activities: * Provide leadership, supervision, and line management of the Regulatory Operation group of 10-15 people responsible for CMC regulatory affairs. * Manage and supervise global regulatory strategies and associated submissions and approvals, achieving regulatory milestones for clinical trials, new submissions, and life cycle management on behalf of clients. * Manage company licenses and certifications. * Review and approve CTD Quality dossier and responses to questions from regulators. * Ensure strict compliance with regulatory requirements and company standards for all registrations and regulatory processes. * Optimize the regulatory process and systems, ensuring effective processes are defined and embedded, and effective risk management with disciplined regulatory compliance. * Deliver regulatory policy and intelligence insights to support the company's strategic priorities. * Build partnerships with regulatory authorities through proactive regulatory authority engagement around the world, including the US and EU. * Serve as a liaison between regulatory authorities and other departments of the company. * Enhance team capabilities through effective coaching and talent development for group members. * Supporting major Global Clients' regulatory filings from within a large scale biologics CMO environment. * Interfacing with, providing observation responses and interacting directly with global regulatory agencies including the FDA and EMA. Desired Skills: * 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry Regulatory Affairs experience with expertise working on developing Biologics, Biopharma, monoclonal antibody, or recombinant protein products. * BS degree in Biology, Chemistry, BioChemistry, Molecular Biology, Chemical Engineering or related Life Sciences field. * Regulatory Affairs experience working from within a major Global BioPharma company or CDMO/CMO (Contract Manufacturing Organization). * Experience interacting directly with global regulatory agencies including the FDA, EMEA, and Health Canada. * Experience maintaining Site Master Files and other regulatory documents a plus. * Strong Quality Systems/Quality Assurance experience executing and generating SOPs within FDA/cGMP compliance. * Proficiency communicating in the Korean language a plus. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Sr. Manager/Director BioPharma Marketing Communications, Expat in South Korea
This is a stellar opportunity responsible for developing and implementing Marketing Communications strategies within the World?s Largest Biologics Contract Manufacturing Organization with expanding commercial monoclonal antibody manufacturing capabilities. This is a once-in-a-lifetime Global Expat leadership opportunity to live and work in the Songdo, South Korea ?City of the Future?. You will be charged with overseeing the following activities: * Developing, implementing and executing marketing and promotional projects to support Executive level leadership and key business stakeholders for the advancement of Biologics CDMO/CMO businesses. * Manage a diverse set of Marketing Communications projects for B2B Healthcare marketing campaigns. * Facilitate collaboration across the company, global institutes, PR/Marketing agencies, and partners to identify communication needs, shared strategies and aligned engagement efforts. * Develop various global PR/marketing vehicles including but not limited to online/digital content, conference/event/sponsorship components, scientific papers, and client-targeted promotion materials. * Develop innovative marketing content via the creation of Online videos and video editing tools. * Managing paid online campaigns via Google, Facebook, Instagram, LinkedIn and other major online sites. * Coordinate and support English based external communications including company website, social media channels, CRM, and industry conferences. * Utilize internal feedback, marketing analytics to monitor and adjust the effectiveness of Marketing Communications strategies and tactics. Desired Skills: * 10+ years of Marketing, Marketing Communications, Public Relations or Advertising Agency experience within a large Global company environment. * BS or MS Degree in Marketing, Communications Management or MBA. * Experience working within the Biotechnology industry, Pharmaceutical Industry, Life Sciences, Healthcare or CDMO/CMO (Contract Manufacturing Organization) preferred. * Expertise in Content Creation, Video Content Production, Video Editing, Digital Marketing and Social Media Management. * Expertise generating online organic and paid media including Google ad placement, web content and white papers. * Expertise utilizing Marketing Automation or CRM software such as Salesforce Pardot for lead management and customer management. * Excellent English verbal and written communication proficiency. * Korean language proficiency required with an emphasis on English fluency & proficiency. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Lead Scientist, Mammalian Cell Line Development
This is a stellar opportunity responsible for leading upstream mammalian cell line development activities and innovative platform development for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Serving as a technical and scientific lead for advanced stable cell line development, cell line optimization and mammalian expression technologies for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. * Leading CLD efforts including DNA cloning, vector construction and the characterization of production cell banks. * Performing clone selection, CHO cell transfection and selection processes to develop stable cell lines with high productivity. * Evaluate and introduce strategic, innovative and novel technologies to improve cell line development processes and therapeutic protein production with the consideration of IP landscape of novel technologies. * Oversee cell line development project plans, including raw materials and equipment availability in preparation of laboratory and pilot-scale runs. * Developing cell line and upstream processes from thaw, pilot scale-up, technology transfer through to clinical manufacturing. * Serving as the technical project lead for the development of robust high performing robust mammalian cell lines with emphasis on transferability to cGMP manufacturing. * Working collaboratively with upstream and downstream process development teams and analytical development teams to support drug substance development. Desired Skills: * 5+ years of Biotechnology industry experience leading mammalian cell line development processes. * MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field. * Cell line development experience for the generation of complex monoclonal antibodies including ADC?s, Bispecific Antibodies or Fusion Proteins. * Expertise utilizing of High-Throughput automated liquid handling systems such as TECAN or Hamilton STAR. * Expertise utilizing AMBR bioreactors, FACS analysis, Flow Cytometry, Octet, Guava or Cedex technologies. * Hands-on expertise in cell banking, cell thawing and cell freezing technologies. * Expertise in DNA cloning, vector construction and design, and genetic characterization of production cell banks. * Knowledge of a variety of cell lines and mammalian expression systems including CHO, HEK and NS0. * Knowledge of PAT technologies, GMP guidelines and prior CMC filing experience. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Senior Director, Analytical Development
This is a stellar opportunity responsible for leading Analytical Development activities within a Clinical Development CDMO organization working on the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CDMO/CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Leading a team of Scientists performing analytical development activities for the characterization of complex monoclonal antibodies including Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques. * Leading analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance. * Leading technology transfer processes and working cross functionally with Quality Control departments. * Designing and conducting stability, impurity and degradation studies. * Leading analytical related process characterization studies. * Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions. * Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes. * Working cross functionally with Cell Lined Development, Process Development, Manufacturing, MSAT, Regulatory, Quality Assurance and Quality Control departments. Desired Skills: * MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field. * 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience. * Protein Analytical expertise developing methods for the characterization of complex monoclonal antibodies including Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. * Experience leading large teams of Scientists performing Analytical Development and Methods Transfer activities for BioPharmaceutical Development and Manufacturing. * Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques. * Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired. * Experience working on technology transfer and validation activities within cGMP compliance. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Director/Head, ADC Manufacturing Business Operations
This is a stellar opportunity charged with starting up and leading Technical and Business Operations for ADC conjugation processes, tech transfer and manufacturing operations. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and new ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Driving and leading the overall ADC business operations including team management, project execution and business delivery including the setting of business goals, resources and budgets. * Driving the startup of ADC plant operations including process development, GMP facility management, process development, scale-up, tech transfer into manufacturing and supply chain operations. * Providing team leadership, mentoring and overall team oversight for process development and production operations teams. * Leading the development & optimization of highly sensitive ADC conjugation processes ensuring quality and safety. * Providing input on payload handling procedures and for facility design from a human safety perspective. * Developing and incorporating site-specific antibody conjugation platform technologies. * Supporting the standardization of processes and communications to build efficiency within cross-functional teams. * Partnering directly with Business Development teams serving as ADC SME and engaging with prospective clients. * Providing input for facility process design, equipment validation and equipment selection. * Providing support for GMP document generation including SOPs and batch records. * Leading and supporting technical process clarification with clients. * Supporting FDA/EMA quality audits and global regulatory inspections. Desired Skills: * 10-15+ years working experience with ADC biopharmaceuticals, including manufacturing process development. * MS or Ph.D. in Biochemistry, Biology, Organic Chemistry, Chemistry, or related Biological Sciences degree. MBA or Advanced Business Degree a plus. * Proven technical experience with ADC conjugation processes, tech transfer and manufacturing operations for commercial ADCs and monoclonal antibody therapeutics. * Financial and Business Operations experience managing P&Ls, complex budgets and financial resources. * Experience managing ADC safety operations including the safe handling of cytotoxic payload compounds as well as adhering to proper EHS standards. * Project Management leadership experiences as well as Lean Six Sigma experience. * Experience contributing to CMC, IND and BLA regulatory filings and submissions with the FDA and EMA. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |
| Sr. Manager/Director, Upstream Process Development
This is a stellar opportunity responsible for leading upstream mammalian cell culture process development and tech transfer activities for the generation of complex molecules including monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities: * Leading the development and implementation of upstream cell culture processes from bench scale, scale-up, pilot scale, technology transfer through to cGMP manufacturing. * Providing technical leadership for developing, optimizing, scaling-up, and validating steps in upstream process development for the generation of complex monoclonal antibodies, ADC?s, Bispecific Antibodies and Fusion Proteins. * Serving as the technical project lead for the development of robust high performing upstream processes with emphasis on transferability to cGMP manufacturing. * Overseeing cell culture-specific project plans, including raw materials and equipment availability, in preparation for laboratory and pilot scale runs. * Serving as technical lead for client development projects, communicating project updates and providing technical explanations and rationalization. * Serving as technical project lead driving the development and implementation of processes from bench to scale-up, including technology transfer through clinical GMP manufacturing. * Driving process innovation initiatives including the implementation of perfusion and continuous manufacturing processes. Desired Skills: * 10+ years of Biotechnology industry experience leading upstream mammalian cell culture process development. * MS or Ph.D. in Chemical Engineering, Biochemistry, Molecular Biology, Biology or related Life Sciences field. * Upstream mammalian cell culture process development experience for the generation of complex monoclonal antibodies including ADC?s, Bispecific Antibodies or Fusion Proteins. * Strong Scientific and Engineering technical experience performing upstream cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development, and stainless steel bioreactor operations for the manufacturing of recombinant proteins, monoclonal antibodies, ADCs or mRNA vaccines. * Subject matter expert in process development areas including high throughput technologies, AMBR bioreactors, perfusion platform technologies or Continuous Manufacturing. * Experience leading cross-functional, multi-national teams including tech transfer teams. * Excellent understanding and working knowledge of cGMP and biopharmaceutical product development lifecycles and regulatory filings (BLA, MAA, IND). * Ability to build and maintain strong, positive relationships with customers. About the Company: Expatriate Benefits Package: * Competitive base salary, target bonus, retirement allowance and excellent medical benefits. * Company paid luxury apartment in Songdo. * International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time. * Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels * Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University. * Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport. You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/ |
Los Angeles, CA |