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 coordinate the worldwide movement of our drugs to patients.
Position: Director - Drug Product Technology Transfer - Cork/Dublin/Remote Closing date: 23 January 2024 Technical 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 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 project execution and delivery of successful process characterization, engineering, process performance, and support to regulatory filing for drug product.
Drive excellence in Tech Transfer execution for Sterile Drug Product.
Project Portfolio Ownership.
Drug Product Technology Transfer and Product Lifecycle Management (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 standardization 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 commercialization strategy.
The role combines scientific, engineering, and operational leadership, requiring familiarity with cGMP and Quality Systems involved in commercial manufacturing processes.
Duties: Leadership: Lead a team of scientists and engineers in the delivery of Tech Transfer 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.
Author, review, and coach staff in regulatory filing submissions.
Create and maintain a teamwork environment, developing and motivating a high-performing team that aligns with organizational values.
Serve as an influential member of the Drug Product and Packaging Development leadership team, impacting decision-making and promoting cross-functional collaboration.
Partner with Drug Product and Packaging Development leadership during GMP audits from regulatory authorities.
Ensure understanding of all quality policies and BioMarin systems as per training curriculums.
Participate in cross-functional teams to troubleshoot and resolve technical issues using root cause analysis tools.
Participate in global partner teams and CMC teams as required.
Skills: Experience in biopharma, process development, and MSAT/Technical Development organizations is desirable.
10+ years of professional experience in the pharmaceutical industry, including managerial experience.
Proven ability to lead and develop effective teams of scientists and engineers.
Broad understanding of drug product development with strong business acumen.
Experience collaborating across functional groups to achieve business objectives.
Effective decision-making skills, with the ability to negotiate and prioritize needs of multiple stakeholders.
Initiative-driven and results-oriented, with a capacity for change management.
Exceptional communication skills for influencing individuals and teams at all organizational levels.
Experience with CAPA, FMEA, RCA tools in a regulated manufacturing environment.
Education: Degree in Engineering, Science, or Business discipline.
PhD or Master's in Science or Engineering preferred.
Location: Ireland - Cork/Dublin/Remote Travel: 15-25% Note: This description is not exhaustive and may include other duties as assigned.
Equal Opportunity Employer/Veterans/Disabled
We are committed to equal employment opportunity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status.
We also do not discriminate against individuals with disabilities.
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