Associate Director, Drug Substance Technology Transfer
2 days ago
Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Associate Director, Drug Substance Technology Transfer - Cork or Dublin (Hybrid) Biologics Centre of Excellence, Drug Substance Technologies are hiring for an Associate Director Drug Substance Technology Transfer to establish a best in class Tech Transfer team in our ever expanding facility in Cork. Technical and Scientific Leadership Provide technical and scientific leadership to the Manufacturing Network through partnerships with global functions and third-party Commercial Manufacturing Organisation's (CMOs) to introduce new products and technologies across our internal & external network. Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing across all modalities. Driving excellence in Tech Transfer execution for Drug Substance Project Portfolio Ownership. Technology Transfer team are responsible for: Being the primary interface between Manufacturing Operations (Drug Substance) and the Drug Substance Technology wider team for Technology Transfer and LCM. The delivery of Technology Transfer across our Manufacturing Network and successful handover to operations team. Supporting the development and execution of the Strategy through Tech Transfer for the operational site. Successful Partnership with Technical Development & Services and Operations in the delivery of the product development pipeline and commercialisation strategy. The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes. Leadership Lead a team of scientists and engineers in the delivery of TT for Drug Substance across our Manufacturing Network. Manage and communicate the project portfolio to key stakeholders. Identify, recruit, develop and retain qualified individuals to lead Tech Transfer for our Manufacturing Network. Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes. Serve as an influential member of the Biologics Centre of Excellence, BCoE leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions. Partner with BCoE leadership to provide technical expertise and discussion during GMP audits from regulatory authorities. Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. Participate in Global Partner Teams and CMC team as required. Experience 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Demonstrated to lead and develop an effective team of scientists and engineers. Proven track record of Technology Transfer in Drug Substance A broad understanding of Drug Product, Small Molecule Devices and a keen sense of business acumen. Experience collaborating effectively with other functional groups to achieve business objectives. Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of multiple stakeholders. Demonstrated initiative; results oriented, initiative to institute change. Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network. Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment. Education Degree in Engineering, Science or Business Discipline. PhD / master's in science or engineering Discipline is preferable. Travel: 20-30% within Europe Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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Cork, Ireland BIOMARIN Full timeWho We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...
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Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
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Director, Drug Product Technology Transfer
2 weeks ago
Cork, Ireland BIOMARIN Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using...
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Director, Drug Product Technology Transfer
2 days ago
Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
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Senior Technical Transfer Engineer
1 week ago
Cork, Ireland Tandem Project Management Limited Full timeSummary: Our client, a biopharmaceutical company located in West Cork, is looking for a Senior Tech Transfer Engineer. The ideal candidate will have the opportunity of supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity...
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Senior Technical Transfer Engineer
2 days ago
Cork, Ireland Tandem Project Management Limited Full timeSummary: Our client, a biopharmaceutical company located in West Cork, is looking for a Senior Tech Transfer Engineer. The ideal candidate will have the opportunity of supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity...
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Cork, Ireland BioMarin International Limited Full timeWho We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...
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Director/Associate Director, Regulatory CMC
2 weeks ago
Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Director/Associate Director, Regulatory CMC
2 days ago
Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Cork, Ireland BioMarin International Limited Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Process Engineer
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Cork, Ireland PE Global Full timePE Global is currently recruiting for a Process Engineer (Tech Transfer) for a leading multi-national Biotech client based in Cork. This is an initial 11-month contract position. Out client is seeking a highly motivated individual for a Technical Transfer position.This area is accountable for technology transfers and commercial production of Large Molecule...
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Cork, Ireland BIOMARIN Full timeBioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose,...
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Associate Director – Clinical Drug Supply
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[3 Days Left] Process Engineer
1 week ago
Cork, Ireland PE Global Full timePE Global is currently recruiting for a Process Engineer (Tech Transfer) for a leading multi-national Biotech client based in Cork. This is an initial 11-month contract position. Out client is seeking a highly motivated individual for a Technical Transfer position.This area is accountable for technology transfers and commercial production of Large Molecule...
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Senior Technical Transfer Engineer
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Senior Technical Transfer Engineer
2 days ago
Cork, Ireland Recruitment by Aphex Group Full timePurpose Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process...
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Senior Tech Transfer Engineer
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Cork, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Technical Transfer Engineer to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Work with External...
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Senior Tech Transfer Engineer
2 days ago
Cork, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Technical Transfer Engineer to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Work with External...
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Associate Director
2 weeks ago
Cork, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy...
