Material Sciences Specialist

The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements. The position will support specification updates, technical data gathering, compendial comparisons, document management, change control execution, and cross-functional implementation activities.

Material Sciences Specialist
Duration: 6 month contract
Location: Onsite in Novato on Tuesday and Wednesday
Pay range: $60.00 - $65.00


Position Summary:
Support execution of a global material specification remediation program associated with regulatory commitments and CAPA activities. The contractor will work closely with Material Sciences, Global Quality, Regulatory Compliance, and Site Quality teams to review, revise, implement, and maintain raw material specifications in accordance with compendial and internal requirements.

This role will provide critical support to accelerate regulatory commitments while enabling Material Sciences personnel to remain focused on strategic product and manufacturing priorities. The position will support specification updates, technical data gathering, compendial comparisons, document management, change control execution, and cross-functional implementation activities.

Key Responsibilities
Specification Remediation
" 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.

Change Control & CAPA Support
" Support initiation and execution of change controls related to specification updates.
" Coordinate impact assessments from affected functional groups.
" Track implementation progress and CAPA milestones.
" Assist with closure documentation and inspection readiness activities.

Data Management & Documentation
" 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.

Cross-Functional Coordination
" Work with Material Sciences, Quality Systems, Quality Control, Regulatory Affairs, Supply Chain, Manufacturing, and Procurement.
" Follow up with SMEs regarding impact assessments and outstanding actions.
" Support meeting preparation and action item tracking.
Inspection Readiness
" Assemble supporting documentation for regulatory inspections and CAPA effectiveness reviews.
" Support ongoing alignment of specifications with compendial and regulatory expectations.

Required 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).

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.





Benefits (employee contribution):
Health insurance
Health savings account
Dental insurance
Vision insurance
Flexible spending accounts
Life insurance
Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act