(CW) Material Sciences Specialist Contract

About the Company

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 our founding in 1997. Our revolutionary treatments for conditions like achondroplasia, PKU (phenylketonuria), CLN2 (a form of Batten disease), and multiple forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. With the recent acquisition of Amicus, our portfolio now includes therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, deep understanding of patient needs, scientific expertise, and world-class manufacturing capabilities. At BioMarin, a dedicated team of industry-leading professionals works together to deliver innovative therapies to patients worldwide.

About Technical Operations

BioMarin’s Technical Operations group is responsible for drug development for clinical trials and scaling production for the commercial market. This team of engineers, technicians, scientists, and support staff builds and maintains cutting-edge manufacturing processes, ensures quality assurance and regulatory compliance, and coordinates the global distribution of our therapies to patients.

About the Role

BioMarin is seeking a temporary contractor to support execution of a global material specification remediation program tied to regulatory commitments and CAPA activities. The contractor will collaborate with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in alignment with compendial and internal requirements. This role will accelerate regulatory commitments while allowing Material Sciences personnel to focus on strategic product and manufacturing priorities.

Onsite in Novato on Tuesday and Wednesday.

Responsibilities

• Review existing raw material specifications against current compendial requirements.
• Compare USP, Ph. Eur., JP, ACS, and supplier specifications where applicable.
• Support revision of excipient, chemical, and process material specifications.
• Compile technical justification packages and supporting rationale for specification updates.
• Support initiation and execution of change controls related to specification updates.
• Coordinate impact assessments from affected functional groups.
• Track implementation progress and CAPA milestones.
• Maintain specification inventories and implementation trackers.
• Generate summary reports and status dashboards.
• Verify technical data consistency across specifications and supporting documents.
• Ensure document formatting aligns with approved specification templates.
• Work with Material Sciences, Quality Systems, Quality Control, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement.
• Follow up with subject matter experts regarding impact assessments and outstanding actions.
• Support meeting preparation and action item tracking.
• Assemble supporting documentation for regulatory inspections and CAPA effectiveness reviews.
• Support ongoing alignment of specifications with compendial and regulatory expectations.

Requirements

• BS degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 3–4 years of experience in pharmaceutical manufacturing, quality, technical services, material sciences, or regulatory compliance.
• Experience working with GMP documentation.
• Strong technical writing and document revision skills.
• Familiarity with change controls, CAPAs, and deviation systems.
• Knowledge of pharmacopeial standards (USP, EP, JP).

Preferred Qualifications

• Experience with raw material specifications and supplier quality systems.
• Understanding of excipient and chemical control strategies.
• Experience supporting regulatory inspections or remediation programs.
• Familiarity with Veeva, document management systems, and electronic quality systems.
• Ability to independently manage multiple workstreams and priorities.

Success Metrics

• Specification revisions completed on schedule.
• Change control support delivered to meet CAPA milestones.
• Impact assessments and implementation activities tracked to completion.
• Inspection-ready documentation maintained.

Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents, and participating in EHS initiatives and training.