Senior Scientist 2, Chemical Development & Manufacturing

BioMarin Pharmaceutical • Novato, CA

6d • Hybrid

About The Position

This exciting role has emerged due to growth in the Chemical Development & Manufacturing group, which is part of the Drug Substance Technologies (DST) group within the Technical Development & Services (TDS) organization. The Chemical Development & Manufacturing group leads the CMC development for all synthetic chemistry programs across Technical Operations (TOPS). The role involves driving clinical programs through Process Performance Qualification (PPQ) as a Partner Team Lead (PTL). This position requires strong cross-functional collaboration, project management skills, and the ability to contribute to group strategy, budget preparation, and program planning. The role also involves identifying and selecting new Contract Development and Manufacturing Organizations (CDMOs), driving the strategy and performance of the CDMO network, anticipating and solving challenges, managing regulatory filings, and supporting internal synthetic chemistry innovation.

Requirements

• Bachelors, Masters or PhD level in Chemistry or Chemical Engineering.
• A combined minimum of 9 years of related experience in synthetic molecule, drug substance development environments and CMC DS program management.
• Working knowledge of pharmaceutical regulatory requirements.
• Solid cGMP skills.
• Excellent written and oral communication skills; expectation to present frequently, at in-house forums.
• Demonstrated capability at handling multiple programs and projects at the same time.
• Agreement to work in a hybrid fashion, spending 2 days per week, on average, at the local BioMarin site.

Nice To Haves

• Post-doctoral experience would be an advantage.
• Business, leadership or related training credentials would be desirable.
• Experience in Oligonucleotide development and/or manufacture would be an advantage.
• Familiarity and/or working with ERP and quality documentation systems are desirable but not required.

Responsibilities

• Drive clinical programs through PPQ as a Partner Team Lead (PTL).
• Collaborate cross-functionally with internal and external groups, including other Drug Substance modality functions, Formulation and Analytical departments, External Manufacturing, Quality, Supply Chain, Research, Regulatory Affairs, Finance, and Legal.
• Manage project management, especially with regard to active programs with Contract Manufacturing and Development Organizations (CDMOs).
• Contribute to group strategy, participating in budget preparation and monitoring, as well as program planning.
• Identify and assist in selection of new CDMOs, building a deep knowledge of the external landscape.
• Drive the strategy and performance of the CDMO network, as well as internal functions, to deliver enterprise and group goals.
• Anticipate scientific, business and program challenges, while working cross functionally to solve problems.
• Manage drafting and delivery of 3.2.S filing sections and address HA questions.
• Perform periodic in-person visits to other BioMarin and CDMO locations for connectivity and alignment, and provide Person-in-plant support.
• Play a part at the forefront of internal synthetic chemistry innovation, identifying, evaluating, and implementing new technologies.
• Share learnings at appropriate platforms.
• Support the organization’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
• Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Benefits

• The role involves driving clinical programs, through PPQ, as a Partner Team Lead (PTL).
• Cross functional collaboration behaviors are critical to the role, where connectivity forms a mainstay of day to day activity.
• Project management, especially with regard to active programs with Contract Manufacturing and Development Organizations (CDMOs), will draw upon excellent written and communication skills, as well as strong leadership behaviors.
• Contribute to the group strategy, participating in budget preparation and monitoring, as well as program planning.
• Identify and assist in selection of new CDMOs, building a deep knowledge of the external landscape.
• Drive the strategy and performance of the CDMO network, as well as the internal functions, to deliver enterprise and group goals.
• Anticipate scientific, business and program challenges, while working cross functionally to solve problems.
• Manage drafting and delivery of 3.2.S filing sections and address HA questions, in appropriate sections.
• Periodic in person visits to other BioMarin and CDMO locations, to ensure continued connectivity and alignment, across the internal network and Person-in-plant support, respectively.
• Play a part at the forefront of internal synthetic chemistry innovation, to ensure new technologies are identified, evaluated and implemented, positioning TDS centrally for cutting edge initiatives and early adaptation.
• Share learnings at appropriate platforms.

What This Job Offers

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