Only 24h Left: Director, Drug Product Technology Transfer
20 hours ago
Who 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 number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations 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. Director - Drug ProductTechnology Transfer - Cork/Dublin/Remote Closing date 23January2024 Technical Development Services (TDS)are hiring fora Director of Drug Product Technology Transfer (Sterile)with the following remit. Provide technical and scientific leadership to the Drug Product Internal and External manufacturing networkthrough partnerships with global functions and third-party Commercial Manufacturing Organisation's (CMOs) to introduce new products and technologies. Provide technical leadership in onboarding new commercial assets across all modalities and ensure their successful integration into the BioMarin Operating Model. Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing for drug product. Driving excellence in Tech Transfer execution for Sterile Drug Product. Project Portfolio Ownership. Drug ProductTechnology Transfer and Product LCM team are responsible for: Being the primary interface between GEO Manufacturing Operations, Internal Drug Product manufacturingandTDS for Technology Transfer and LCM. The delivery of Technology Transfer across the Global External Operations and internalManufacturing Network and successful handover to operations team. Development and implementation of Tech Transfer best practices and standardisation across theInternal and external manufacturing network. Supporting the development and execution of the Network Operations Strategy through Tech Transfer. Successful 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. Duties: Leadership: Lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network. Manage and communicate the project portfolio to key stakeholders. Identify, recruit, develop and retain qualified individuals to lead Tech Transfer. Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions. 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 Drug Product and Packaging Development leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions. Partner with Drug Product and Packaging Development 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. Skills: Experience in the Biopharma, experience in Process Development and MSAT/ Technical Development organizations is desirable. 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Demonstrated to lead and develop an effective team of scientists and engineers. A broad understanding of Drug Productand 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. Location Ireland - Cork/Dublin/Remote Travel: 15-25% Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 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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Director, Drug Product Technology Transfer
7 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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Associate Director, Drug Substance Technology Transfer
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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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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 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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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 around the world 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...
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Cork, Ireland Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
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(Only 24h Left) Packaging Technician
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▷ [Apply Now] Process R&D Director (Cork)
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Only 24h Left: Project Engineer
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Technical Development Scientist
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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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(Apply in 3 Minutes) Associate Director
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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 around the world 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...
