Contractor - Material Specs Lead (Pharma GMP)

BioMarin Pharmaceutical Inc.

Novato (CA)

On-site

USD 55,000 - 83,000

Full time

14 days+

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Job summary

BioMarin Pharmaceutical Inc. is seeking a temporary contractor to support a global material specification remediation program.

You will work with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality to review, revise, and maintain raw material specifications in line with compendial and internal requirements. The role focuses on remediation, technical data gathering, changes controls, and CAPA support, ensuring inspection readiness while accelerating regulatory commitments

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

Support specification remediation for raw material specifications.
Coordinate change control activities and CAPA milestones.
Maintain specification inventories and tracking dashboards.
Collaborate with Material Sciences, Quality Systems, Regulatory Affairs, and Manufacturing.
Assist with inspection readiness documentation and regulatory reviews.