Job Title – QC Senior Scientist, Stability and Reference Standard Specialist
Work Location – Cranbury, NJ
WuXi Biologics is a 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
Job Summary
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
Qualifications:
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
End-to-end management of GMP stability studies, including sample receipt, aliquoting, storage, pulling, distribution, and lifecycle oversight
- 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 requalification protocols and reports
- Technical review and approval of analytical test results, raw data, and worksheets
- Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and data integrity principles (ALCOA+)
- GMP documentation authoring and review, including SOPs, protocols, reports, deviations, and change controls
- Proficiency with LIMS, stability databases, and electronic quality management systems
- Advanced data analysis and trending using Microsoft Excel or equivalent tools
Preferred Experience:
- Experience serving as a subject matter expert during regulatory inspections and client audits
- Familiarity with statistical tools or software for stability trending and data evaluation
- Experience supporting clinical and/or commercial product stability programs
- Experience working in a CDMO or client-facing QC environment
- Knowledge of global regulatory expectations (FDA, EMA, ICH)
- Experience driving continuous improvement or process optimization initiatives
- Familiarity with electronic laboratory notebooks (ELN) and digital documentation systems
Communication Skills:
- Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills). Must be able to collaborate with clients and internal, and support cross functions to achieve alignment and work effectively.
The pay range for this position is 60,200-96,300
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability