Sr. Scientist 1
BioMarin Pharmaceutical Inc.
August 31, 2026
Remote friendly (Novato, CA)
United States
$130,400 - $179,300 USD yearly
Clinical Research and Development
Role Summary:
Oversee drug product development and manufacturing activities (SME in drug product formulation development or Drug Product Partner Team Lead). Serve as scientific monitor for formulation development, technology transfer, and manufacturing at CDMOs/CMOs. Knowledge of GMP requirements is preferred.
Responsibilities:
- Plan experimental strategy and formulation development for small molecules, oligos, and peptides across non-clinical and clinical phases.
- Lead drug product formulation development and optimization.
- Provide scientific guidance to junior scientists (design, troubleshooting, data interpretation).
- Design experiments/technical strategies to resolve formulation and process issues.
- Lead cross-functional CMC Drug Product Partner Team; coordinate recommendations for CMC decision-making.
- Ensure clear communication of project status, issues, strategies, and risks to CMC leadership.
- Track/report milestones and deliverables; represent DP team in Core Team meetings.
- Support CDMO selection, due diligence, and site evaluations.
- Review protocols/reports; review technical documentation and contribute to regulatory submission content.
Qualifications:
- Ph.D. in Biochemistry/Pharmaceutics Sciences (or related) with 5+ years industry experience; or MS/BS with extensive industry experience.
Experience/Skills (Required):
- Lead cross-functional, multi-disciplinary planning/monitoring/execution of deliverables.
- Hands-on solid oral dosage form development (pre-formulation; tablets/capsules/oral solutions).
- Parenteral drug product formulation development, characterization/testing, quality risk assessment, and CMC regulatory guidance/filings.
- Strong leadership/team management; organization/prioritization; written/verbal communication.
- Technical writing experience for development reports, batch records, and regulatory filings.
Preferred:
- Parenteral formulation screening/optimization; gene therapy drug product development; experience with GMP.
Work Environment:
- Hybrid; 2–3 days onsite in Novato, CA.
Oversee drug product development and manufacturing activities (SME in drug product formulation development or Drug Product Partner Team Lead). Serve as scientific monitor for formulation development, technology transfer, and manufacturing at CDMOs/CMOs. Knowledge of GMP requirements is preferred.
Responsibilities:
- Plan experimental strategy and formulation development for small molecules, oligos, and peptides across non-clinical and clinical phases.
- Lead drug product formulation development and optimization.
- Provide scientific guidance to junior scientists (design, troubleshooting, data interpretation).
- Design experiments/technical strategies to resolve formulation and process issues.
- Lead cross-functional CMC Drug Product Partner Team; coordinate recommendations for CMC decision-making.
- Ensure clear communication of project status, issues, strategies, and risks to CMC leadership.
- Track/report milestones and deliverables; represent DP team in Core Team meetings.
- Support CDMO selection, due diligence, and site evaluations.
- Review protocols/reports; review technical documentation and contribute to regulatory submission content.
Qualifications:
- Ph.D. in Biochemistry/Pharmaceutics Sciences (or related) with 5+ years industry experience; or MS/BS with extensive industry experience.
Experience/Skills (Required):
- Lead cross-functional, multi-disciplinary planning/monitoring/execution of deliverables.
- Hands-on solid oral dosage form development (pre-formulation; tablets/capsules/oral solutions).
- Parenteral drug product formulation development, characterization/testing, quality risk assessment, and CMC regulatory guidance/filings.
- Strong leadership/team management; organization/prioritization; written/verbal communication.
- Technical writing experience for development reports, batch records, and regulatory filings.
Preferred:
- Parenteral formulation screening/optimization; gene therapy drug product development; experience with GMP.
Work Environment:
- Hybrid; 2–3 days onsite in Novato, CA.