QC Senior Scientist, Stability and Reference Standard Specialist
Listed on 2026-02-19
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Quality Assurance - QA/QC
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Healthcare
Data Scientist, Medical Science
QC Senior Scientist, Stability and Reference Standard Specialist
United States Posted
Job Title –QC Senior Scientist, Stability and Reference Standard Specialist
Work Location – Cranbury, NJ
WuXi Biologics
is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD
culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies
The Senior QC Scientist will lead and manage GMP Quality Control (QC) stability programs and reference standard (RS) lifecycle activities in support of clinical and/or commercial manufacturing. This role provides technical leadership in stability study design, protocol authorship, data review, trending, and client deliverables. The Senior QC Scientist will serve as a subject matter expert (SME) for stability and reference standards, ensuring compliance with GMP and regulatory expectations.
Responsibilities- Lead and manage QC stability study programs, including sample receipt, aliquoting, storage, pulling, distribution, and lifecycle oversight
- Author, review, and approve stability study protocols, reports, and related GMP documentation
- Perform technical review and approval of stability test results, worksheets, and trend analyses
- Ensure timely preparation and delivery of stability reports and Certificates of Analysis (CoAs) to external clients
- Monitor, trend, and interpret stability data; identify atypical results and lead investigations or impact assessments as needed
- Serve as SME for stability studies and reference standard management during audits, inspections, and client interactions
- Oversee reference standard receipt, aliquoting, storage, inventory control, distribution, qualification, and requalification
- Author and approve reference standard aliquoting, qualification, and requalification protocols and reports
- Ensure reference standards remain qualified and available to support uninterrupted GMP testing
- Drive continuous improvement initiatives related to stability, reference standards, and GMP documentation
- Coordinate with QC Functional Leads (QCFL) to ensure timely cleanup, reconciliation, and disposal of project-related stability and reference standard samples upon project completion
- Support QC inventory management activities, including documentation control and archival
- Perform all activities in compliance with applicable safety policies, quality systems, and cGMP requirements
- Mentor junior QC staff and provide technical guidance
- Perform other duties as assigned by management to support overall QC operations
Education and Experience
- Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline (Master’s or PhD preferred)
- 5+ years of GMP Quality Control experience, with demonstrated expertise in stability studies and/or reference standards
- Strong knowledge of GMP regulations, data integrity principles, and ICH stability guidelines
- Proven experience authoring and approving GMP protocols, reports, and technical documentation
- Excellent technical writing, communication, and time management skills
- Ability to independently manage complex projects and multiple priorities in a fast-paced, regulated environment
- Authoring, reviewing, and approving stability study protocols, reports, and Certificates of Analysis (CoAs)
- Stability data trending, evaluation, and interpretation in alignment with ICH guidelines (e.g., ICH Q1A/Q1E)
- Investigation and documentation of atypical, OOS, and OOT results
- Reference standard (RS) lifecycle management, including receipt, aliquoting, storage, inventory control, qualification, and requalification
- Authoring and approval of RS aliquoting, qualification, and…
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