Director, Technology Transfer and Product Life Cycle Management

BioMarin Pharmaceutical Inc. • San Rafael, CA

3d • Hybrid

About The Position

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.
Job Summary
Hybrid role requiring 2 days onsite per week in San Rafael, CA.
Technical Development and Services (TDS) are hiring a Director for Technology Transfer and Product Life Cycle Management with the following remit.
Provide technical and scientific leadership to the Global External Operations site and Shanbally Drug Product site through partnerships with global functions and third-party Commercial Manufacturing Organization’s (CMOs) to introduce new products and technologies across our external network.
Accountable for the project execution and delivery of successful process characterization, engineering, process performance and support to regulatory filing across all modalities.
Driving excellence in Tech Transfer execution for Sterile and Non-Sterile Drug Product.
Development and execution of Life Cycle Management Strategy across internal and CMO network.
Technology Transfer and Product LCM team are responsible for:
Being the primary interface between Manufacturing Operations and the TDS wider team for Drug Product Technology Transfer and LCM.
The delivery of Technology Transfer and Product Life Cycle projects across the Internal and Global External Operations Manufacturing Network and successful handover to operations team.
Successful Partnership with Technical Development in the delivery of the product development pipeline and commercialization 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.

Requirements

• Experience in the Biopharma, experience in Process Development and MSAT 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.
• Degree in Engineering, Science or Business Discipline.

Nice To Haves

• Experience with small commercialization and support of peptides and oligosaccharides desirable
• PhD / master’s in science or engineering Discipline is preferable.

Responsibilities

• Lead a team of scientists and engineers in the delivery of TT and LCMs for Drug Product both sterile and non-sterile.
• Identify, recruit, develop and retain qualified individuals to lead Tech Transfer and product LCM.
• Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organization values and attributes.
• Serve as an influential member of the Formulation and Product Technology Leadership (FPT) team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions.
• Partner with FPT 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager