Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
Key Highlights:
Oversee execution of stability studies at CMOs and contract testing laboratories.
Perform statistical analysis and trending of stability data using JMP
Support determination of drug substance and drug product shelf life/retest period according to ICH guidelines.
Author and review stability protocols, reports, SOPs and regulatory documentation.
Essential Duties & Responsibilities:
Develop stability strategies aligned with product development objectives, manufacturing plans, clinical supply requirements, and regulatory expectations.
Define appropriate storage conditions, testing intervals, analytical test panels, acceptance criteria, and study durations.
Author, review and revise stability protocols, interim and final stability reports, SOPS, technical memoranda, specifications, and related controlled documents.
Perform comprehensive review, trending, and statistical analysis of stability data to assess degradation rates, variability, lot-to-lot differences, and longitudinal trends.
Use JMP statistical software for regression analysis, graphical evaluation, shelf-life projections, retest period assessments, and other stability-related statistical evaluations.
Identify emerging trends, meaningful changes, OOT results, OOS results, atypical findings, and potential product-quality or clinical-supply risks.
Support establishment and justification of drug substance retest periods and drug product shelf life or expiration dating.
Participate in or lead stability-related investigations, deviations, CAPAs, change controls, and other applicable Quality System records.
Evaluate temperature excursions during product storage and transportation and assess potential product impact using available stability data.
Collaborate with Quality Assurance, Regulatory Affairs, Process Development, Supply Chain, Clinical Supply, and external partners.
Identify and implement opportunities to improve stability processes, statistical methods, documentation, and external-partner performance.
Independently manage multiple studies, priorities, external partners, and timelines in a remote working environment.
Required Skills:
Preferred Skills:
Education:
Numbers & Facts
Location
San Francisco, CA
Skills
Analysis Skillsunmatched
Analysis Softwareunmatched
Analytical Developmentunmatched
CMOSunmatched
Candidate Pipelineunmatched
Change Controlunmatched
Data Analysisunmatched
Document Managementunmatched
Documentationunmatched
Drug Productsunmatched
Healthcare Qualityunmatched
ICH Regulationsunmatched
Insurance Regulationsunmatched
Manufacturingunmatched
Process Developmentunmatched
Process Improvementunmatched
Product Developmentunmatched
Quality Assuranceunmatched
Regression Testingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Sales Pipelineunmatched
Stability Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Statistical Analysis System (SAS)unmatched
Statisticsunmatched
Statistics Softwareunmatched
Strategic Planningunmatched
Supply Chainunmatched
Test Labunmatched
Trend Analysisunmatched
Writing Skillsunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.