Sr. Scientist 1

biomarin; Novato (CA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

BioMarin, a leader in biotechnology for rare diseases, is seeking a highly motivated individual to oversee drug product development and manufacturing activities. This role involves collaboration with multidisciplinary teams to ensure project success and compliance.

Ideal candidates hold a Ph.D. in Biochemistry and possess strong leadership and communication skills. The position is hybrid, requiring 2-3 days onsite in Novato, CA.

Qualifications

• Ph.D. with 5+ years of industry experience required.
• Experience leading multi-disciplinary teams for drug development.
• Strong technical writing skills for regulatory documents.

Responsibilities

• Oversee formulation development and manufacturing activities.
• Collaborate with cross-functional teams to deliver project objectives.
• Identify and mitigate risks related to project timelines and quality.

Skills

Leadership

Team management

Communication skills

Organization and prioritization

Education

Ph.D. in Biochemistry

MS or B.S. with extensive industry experience

Tools

HPLC

Pharmaceutical characterization equipment

Job description

Company Overview

BioMarin 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.

About Technical Operations

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.

Role Summary

BioMarin 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.

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 B.S. with extensive industry experience.

Experience Required

• 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 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, and adapt quickly to changes.
• 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 detail.
• 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), and so on.
• 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
• Reliability
• Teamwork

Work Environment

Hybrid – 2–3 days onsite in Novato, CA.

Additional Information

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

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.