Sr. Scientist 1

About the role

BioMarin 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.

Responsibilities

• 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.
• Serves as the scientific monitor for formulation development, technology transfer, and manufacturing activities conducted at CDMOs/CMOs.
• 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.

Requirements

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables.
• Experience with 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 strong team player with good collaborative and people skills.
• Strong organization and prioritization skills, ability to facilitate and drive program forward.
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes.
• The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.
• Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.
• Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.

Qualifications

• Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 5+ years of industry experience.
• MS or BS with extensive industry experience.