Senior Scientist 2, Chemical Development & Manufacturing
BioMarin Pharmaceutical Inc.
August 31, 2026
Remote friendly (Novato, CA)
United States
Operations
Senior Scientist 2, Chemical Development & Manufacturing
Role Responsibilities:
- Drive clinical programs through PPQ as a Partner Team Lead (PTL).
- Collaborate cross-functionally with Drug Substance modality functions, Formulation, Analytical, External Manufacturing, Quality, Supply Chain, and enterprise teams (Research, Regulatory Affairs, Finance, Legal).
- Identify and assist in selection of new CDMOs; build knowledge of the external landscape.
- With the DS team, drive strategy and performance of the CDMO network and internal functions to deliver enterprise/group goals.
- Anticipate and resolve scientific, business, and program challenges.
- Manage drafting and delivery of 3.2.S filing sections and address HA questions.
- Conduct periodic in-person visits to BioMarin and CDMO locations for alignment and person-in-plant support.
- Lead internal synthetic chemistry innovation: identify, evaluate, and implement new technologies; share learnings.
- Contribute to strategy, budget preparation/monitoring, and program planning.
Qualifications (Minimum Requirements):
- BS/MS/PhD in Chemistry or Chemical Engineering (post-doctoral experience a plus; business/leadership training desirable).
- 9+ years combined experience in synthetic molecule, drug substance development, and CMC DS program management.
- Working knowledge of pharmaceutical regulatory requirements and solid cGMP.
- Excellent written and oral communication; frequent in-house presentations.
- Ability to handle multiple programs/projects concurrently.
- Hybrid work: ~2 days/week on-site.
- Travel: 20–30%.
Nice to Have:
- Experience in oligonucleotide development and/or manufacture.
- Familiarity working with ERP and quality documentation systems.
Ireland Safety Responsibility:
- Support EHS by identifying hazards, reporting incidents, and participating in EHS initiatives and training.
Role Responsibilities:
- Drive clinical programs through PPQ as a Partner Team Lead (PTL).
- Collaborate cross-functionally with Drug Substance modality functions, Formulation, Analytical, External Manufacturing, Quality, Supply Chain, and enterprise teams (Research, Regulatory Affairs, Finance, Legal).
- Identify and assist in selection of new CDMOs; build knowledge of the external landscape.
- With the DS team, drive strategy and performance of the CDMO network and internal functions to deliver enterprise/group goals.
- Anticipate and resolve scientific, business, and program challenges.
- Manage drafting and delivery of 3.2.S filing sections and address HA questions.
- Conduct periodic in-person visits to BioMarin and CDMO locations for alignment and person-in-plant support.
- Lead internal synthetic chemistry innovation: identify, evaluate, and implement new technologies; share learnings.
- Contribute to strategy, budget preparation/monitoring, and program planning.
Qualifications (Minimum Requirements):
- BS/MS/PhD in Chemistry or Chemical Engineering (post-doctoral experience a plus; business/leadership training desirable).
- 9+ years combined experience in synthetic molecule, drug substance development, and CMC DS program management.
- Working knowledge of pharmaceutical regulatory requirements and solid cGMP.
- Excellent written and oral communication; frequent in-house presentations.
- Ability to handle multiple programs/projects concurrently.
- Hybrid work: ~2 days/week on-site.
- Travel: 20–30%.
Nice to Have:
- Experience in oligonucleotide development and/or manufacture.
- Familiarity working with ERP and quality documentation systems.
Ireland Safety Responsibility:
- Support EHS by identifying hazards, reporting incidents, and participating in EHS initiatives and training.