Director, Drug Product Technology Transfer

Job title:

Director, Drug Product Technology Transfer

Company

BioMarin

Job description

DescriptionWho We AreBioMarin 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 OperationsBioMarin’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 Product Technology Transfer – Cork/Dublin/RemoteClosing date 23 January 2024Technical Development Services (TDS) are hiring for a Director of Drug Product Technology Transfer (Sterile) with the following remit.

• Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through 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 Product Technology Transfer and Product LCM team are responsible for:

• Being the primary interface between GEO Manufacturing Operations, Internal Drug Product manufacturing and TDS for Technology Transfer and LCM.
• The delivery of Technology Transfer across the Global External Operations and internal Manufacturing Network and successful handover to operations team.
• Development and implementation of Tech Transfer best practices and standardisation across the Internal 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 Product 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.

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/DisabledAn 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.

Expected salary

Location

Cork

Job date

Sat, 14 Dec 2024 01:36:47 GMT

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