Search TSR Jobs

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Stability Associate Scientist

Job Description

  • Location: New Brunswick, New Jersey
  • Type: Contract
  • Job #79884

Our client, a leading pharmaceutical company, is hiring a Stability Associate Scientist, on a contract basis.

Job ID #: 79884

Work Location:
New Brunswick, NJ or Devens, MA – 100% on site

The Global Biologic Stability (GBS) team manages the stability programs for 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 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.


  • (MS) or BS degree required with relevant cGMP experience in biopharma
  • 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
  • Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
  • Ability to work collaboratively in a team matrix environment is required.
  • Significant experience with evaluating and interpreting stability data using statistical software.
  • Working knowledge of biologics drug substance manufacturing and drug product filling operations and good understanding of analytical and microbiological methods.
  • Exhibit strong leadership and decision making skills especially in problem solving and analytical thinking.
  • Experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability trouble-shooting
  • Experience with front room FDA/health authority inspectional experience.
  • Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
  • Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
  • Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.


  • Accountable for end-to-end program management for biologics marketed product stability program
  • 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.
  • Perform change control impact assessments and document the assessments in change controls. Review and endorse change controls as required.
  • Author change controls for changes to stability program/operations.
  • Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies.
  • Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses, regulatory submissions, Annual Product Quality Reviews (APQR), internal reports, etc.
  • Authors stability sections of regulatory submissions (CTD dossiers for post-approval filings, annual reports, product renewals, health authority queries), APQR, and internal reports.
  • Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes.
  • 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.
  • Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed.
  • 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).
  • Expected to critically evaluate situations and make decisions that require choosing between multiple options, or develop new options, to resolve moderately complex problems.
  • Acts as an advisor/mentor to stability staff.
  • Good organization skills and keen attention to detail.
Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!