Sr. Scientist 1

Company Overview

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since 1997. Our revolutionary treatments for conditions such as achondroplasia, PKU, CLN2, and various forms of MPS offer new possibilities for patients and families who previously had few, if any, available options.

With the acquisition of Amicus, our portfolio now includes therapies for Fabry disease and Pompe disease, expanding our reach to more people living with rare genetic conditions. Our success is rooted in commitment to excellence, deep patient understanding, scientific expertise, and world‑class manufacturing capabilities.

Technical Operations builds and maintains cutting‑edge manufacturing processes and sites, providing quality assurance and control, ensuring regulatory compliance, procuring goods and services, and coordinating worldwide distribution of our drugs.

Bio Marin seeks a highly motivated individual with drug product development experience—preferably in solid oral dosage forms—to oversee development and manufacturing activities. The role may be filled as a subject‑matter expert (SME) or as a Drug Product Partner Team Lead.

• 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 fields with 5+ years of industry experience.

MS or B.S. with extensive industry experience.

• Experience leading a multi‑disciplinary team and providing oversight of cross‑functional activities, ensuring successful planning, monitoring, and execution of deliverables.
• Experience designing parenteral formulation screening and optimization studies; experience in gene therapy drug product development is preferred.
• Hands‑on experience in solid oral dosage form development, including pre‑formulation and formulation of tablets, capsules, and oral solutions.
• Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings.
• Strong leadership and team management skills; a collaborative team player with good interpersonal skills.
• Strong organization and prioritization skills, ability to facilitate and drive programs forward.
• Strong written and verbal communication skills, and familiarity with representation on inter‑disciplinary and cross‑functional…