Contract Material Sciences Specialist – GMP Specs

biomarin; Novato (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

BioMarin is seeking a temporary contractor to support a global material specification remediation program. You will work with Quality, Regulatory Compliance, and Site teams to review, revise, implement, and maintain raw material specifications in line with compendial and internal requirements.

The role emphasizes data management, change control execution, and cross-functional coordination to accelerate regulatory commitments while maintaining inspection readiness.

Qualifications

• 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).

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, where appropriate.
• Coordinate impact assessments from affected functional groups.
• Track implementation progress and CAPA milestones.
• Assist with closure documentation and inspection readiness activities.
• Maintain specification inventories and implementation trackers.
• Generate summary reports and status dashboards.
• Verify technical data consistency across specifications and supporting documents.

Skills

GMP documentation

Technical writing

Change control

CAPA

Deviation systems

Education

BS in Chemistry/Pharmaceutical Sciences/Chemical Engineering or related

Tools

Veeva

Electronic quality systems

Job description

BioMarin is seeking a temporary contractor to support a global material specification remediation program. You will work with Quality, Regulatory Compliance, and Site teams to review, revise, implement, and maintain raw material specifications in line with compendial and internal requirements.

The role emphasizes data management, change control execution, and cross-functional coordination to accelerate regulatory commitments while maintaining inspection readiness.