Stability Associate Scientist

Position Summary
The Global Biologic Stability (GBS) team manages the stability programs for Client's commercial biologics Drug Substances and Drug Products. The global stability program supports all internal and external manufacturing sites. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs. Activities include (but are not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation, review, and approval of stability protocols, reports, and regulatory filings.

Key Responsibilities

1. Accountable for end-to-end program management for biologics marketed product stability program, including:
2. Stability product strategy: determines/communicates stability requirements (e.g. Health Authority annual commitments, product/process change qualification batches, etc.) and assists with identifying production batches that meet these defined requirements for inclusion in the stability program.
3. Perform change control impact assessments and document the assessments in change controls. Review and endorse change controls as required.
4. Author change controls for changes to stability program/operations.
5. Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies.
6. Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses, regulatory submissions, Annual Product Quality Reviews (APQR), internal reports, etc.
7. Authors stability sections of regulatory submissions (CTD dossiers for post-approval filings, annual reports, product renewals, health authority queries), APQR, and internal reports.
8. Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes.
9. Develop and maintain expertise on the overall stability performance of biologic products, including maintaining a working knowledge of the attributes that impact product performance/stability profile.
10. Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed.
11. Expected to work with limited oversight from direct manager; but expected to identify and promptly escalate to management any critical issues related to stability program (e.g. potential impact to regulatory commitments, lab capacity, stability storage capacity).
12. Expected to critically evaluate situations and make decisions that require choosing between multiple options, or develop new options, to resolve moderately complex problems.
13. Acts as an advisor/mentor to stability staff.
14. Good organization skills and keen attention to detail.

Qualifications & Experience

1. (MS) or BS degree required with relevant cGMP experience in biopharma at Client or other company.
2. Strong working knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
3. Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
4. Ability to work collaboratively in a team matrix environment is required.
5. Significant experience with evaluating and interpreting stability data using statistical software.
6. Working knowledge of biologics drug substance manufacturing and drug product filling operations and good understanding of analytical and microbiological methods.
7. Exhibit strong leadership and decision-making skills especially in problem solving and analytical thinking.
8. Experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability trouble-shooting.
9. Experience with front room FDA/health authority inspectional experience.
10. Works independently, reviews data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
11. Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
12. Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.