WuXi Biologics · 5 hours ago
QC Senior Scientist, Stability and Reference Standard Specialist
Cranbury, NJ
Full-time
Onsite
Senior Level
$60K/yr - $96K/yr
5+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics. The Senior QC Scientist will lead and manage GMP Quality Control stability programs and reference standard lifecycle activities, providing technical leadership and ensuring compliance with GMP and regulatory expectations.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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 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
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
South China Morning Post
2026-01-23
South China Morning Post
2026-01-19
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