Material Sciences Specialist

Location: Novato, CA 94949 | Type: Contract | Compensation: $57–$62.07/hour

About the role

Leading biotechnology company seeking an experienced Material Sciences Specialist for a hybrid contract role (Tuesday and Wednesday onsite, 8 AM–5 PM).

Responsibilities

• Support execution of a global material-specification remediation program tied to regulatory commitments and CAPA activities.
• Collaborate with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw-material specifications in line with compendial and internal requirements.
• Review existing raw-material specifications against current compendial standards (USP, Ph. Eur., JP, ACS) and supplier specifications.
• Revise excipient, chemical, and process-material specifications.
• Compile technical-justification packages and supporting rationale for specification updates.
• Initiate and execute change controls related to specification updates.
• Coordinate impact assessments from affected functional groups and track implementation progress and CAPA milestones.
• Maintain specification inventories, generate summary reports, and verify data consistency across documents.
• Collaborate with cross-functional teams (Quality Systems, Regulatory Affairs, Supply Chain, Manufacturing, Procurement).
• Assist with meeting preparation, impact-assessment follow-ups, and action-item tracking.
• Prepare documentation for regulatory inspections and CAPA reviews.
• Ensure specifications align with regulatory expectations and remain inspection-ready.

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.
• Support experience with regulatory inspections or remediation programs.
• Familiarity with Veeva, document-management systems, and electronic quality systems.
• Ability to independently manage multiple workstreams and priorities.

Schedule

Monday–Friday, 8 AM–5 PM (Tuesday and Wednesday onsite).

Benefits

• Medical, dental, and vision coverage.
• Spending accounts.
• Life insurance and voluntary plans.
• 401(k) plan participation.