Sr. Scientist 1

BioMarin Pharmaceutical Inc.; Novato (CA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a highly motivated individual for a role involving drug product development and manufacturing in Novato, CA. The ideal candidate will have a Ph.D. in Biochemistry or related fields and at least 5 years of industry experience.

The position requires leadership skills and the ability to manage cross-functional teams, ensuring timely communication and execution of project objectives in a hybrid work environment.

Qualifications

• 5+ years of industry experience in drug product development.
• Experience leading multi-disciplinary teams.
• Strong written and verbal communication skills.

Responsibilities

• Oversee drug product development and manufacturing activities.
• Lead the cross-functional CMC Drug Product Partner Team.
• Coordinate with partner teams for CMC decision-making.

Skills

Leadership skills

Collaborative abilities

Communication skills

Technical writing

Organizational skills

Problem-solving skills

Education

Ph.D. in Biochemistry or related field

MS or BS with extensive industry experience

Tools

HPLC

DSC

UV spectrophotometry

Job description

Role Summary

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.

Role and 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.


• 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.

Education Required

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

MS or BS with extensive industry experience.

Experience Required

• 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.


• 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.

Supervisor Responsibility

May lead 1-2 associates.

Competencies Required

• Strong leadership, negotiation, and influencing skills.


• Well‑developed organization skills with exact attention to details.


• Strong deductive reasoning skills.


• Excellent written and verbal communication skills.

Technical expertise

• Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC (RP‑HPLC, SEC, ion exchange chromatography), DSC, UV spectrophotometry, particle size measurement techniques, DLS, Differential Scanning Fluorimetry (DSF).


• Operational knowledge and experience with small molecules, oligos and peptides fill finish operation and tech transfer.


• Familiarity with parenteral dosage forms, manufacturing processes, and packaging components is a plus.


• Critical thinking and evaluation.


• Influencing.


• Organizational Awareness.


• Performance Management.


• Self‑Knowledge.

Behavioral

• Accountability


• Achieving Excellence


• Communication


• Courage / Challenge


• Develop Self & Others


• Judgement


• ReliabilityTeamwork

Work Environment

Hybrid - would require 2-3 days onsite in Novato, CA.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.