Sr. Scientist

About Technical Operations

Bio Marin’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 Bio Marin’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.

Bio Marin is seeking a highly motivated individual with drug product development experience—preferably in solid oral dosage forms—to oversee drug product development and manufacturing activities. This role may be fulfilled as a subject‑matter expert (SME) in drug product formulation development or as a Drug Product Partner Team Lead. The Drug Product Partner Team is responsible for all aspects of drug products and finished goods development in support of CMC deliverables.

The team is cross‑functional and includes representatives from Formulation Product Technology (FPT), Drug Substance, Analytical Development, Manufacturing, Packaging and Engineering Development, along with other key functional groups.

The successful candidate will bring broad and deep expertise in drug product development, including but not limited to technology transfer, formulation development (small molecules, oligos, peptides) and optimization, primary packaging design, drug product process development, fill/finish process development and optimization, primary and secondary labeling and packaging development, and shipping design and qualification. The individual is expected to routinely report on project activities, issues, strategies, and risks to CMC leadership and management.

This role also serves as the scientific monitor for formulation development, technology transfer, and manufacturing activities conducted at CDMOs/CMOs. Knowledge of GMP requirements is preferred.

• Plans experimental strategy and formulation development across non‑clinical and clinical phases for small molecules, oligos, and peptides.
• Collaborates within a matrix organization (Research, PD, QC, Drug Substance, Analytical, MSAT, Manufacturing, CDMOs/CMOs, Market Planning, Regulatory) to deliver project objectives.
• Provides scientific guidance to junior scientists on experimental design, troubleshooting, data interpretation, and technical challenges.
• Designs experiments and technical strategies to address formulation and process issues.
• Leads drug product formulation development and optimization.
• Leads the cross‑functional CMC Drug Product Partner Team and represents the team in CMC forums.
• Coordinates with other partner teams to develop recommendations and options for CMC decision‑making.
• Interprets experimental outcomes and provides integrated recommendations to CMC teams.
• Ensures timely, clear communication between the Drug Product Partner Team, CMC team, and functional management.
• Identifies, mitigates, and escalates risks related to quality, timelines, and scope.
• Accountable for tracking and reporting milestones and deliverables to the CMC Project Manager.
• Represents the Drug Product team at Core Team meetings and is accountable for DP deliverables.
• Supports CDMO selection, due diligence, and site evaluations.
• Reviews and provides input on protocols and reports supporting formulation development, tech transfer, and manufacturing.
• Reviews technical documentation and contributes to regulatory submission content.
• Contributes to the overall strategy, performance, and direction of the Chemical, Drug Product, and Device Technologies function.

• Ph.D. in Biochemistry, Pharmaceutics Sciences, or related field with 5+ years of industry experience (or MS or BS with extensive industry experience).
• Experience leading multi‑disciplinary team and providing oversight of cross‑functional activities within the team.
• Experience with designing parenteral formulation screening and optimization studies; experience in gene therapy drug product development preferred.
• Hands‑on experience in…