Stability Scientist

Up to US$45 per hour + Highly Competitive Salary
  1. Contract
  2. Biological Sciences, Medicinal Chemistry, Pharmacokineticists
  3. United States
Cambridge, USA
Posting date: 12 Sep 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Stability Scientist for a leading biopharmaceutical company located in Cambridge, MA.

Must be eligible to work in the US.

Job Responsibilities:

  • responsible for stability support of siRNA drug substances, drug products, intermediates and critical raw materials
  • Organize the stability testing program for specified developmental, clinical and commercial programs. 
  • Contribute to the design of, and analyze data obtained from special use studies including stress and forced degradation, photostability, excursion management, compatibility, and in-use studies. 
  • Monitor team performance against plan and act where targets could be missed.
  • Prepare stability plan with stakeholders. 
  • Author and review stability SOPs and protocols in accordance with company and regulatory guidelines.
  • Analyze and trend stability data, assist in deriving stability specifications.  Provide stability expertise to risk assessment process.
  • Author and review stability reports.
  • Author and contribute analytical data to stability sections of regulatory submissions.  Assist with responses to agency requests. 
  • Manage stability deviation and out of trend process.
  • Develop training materials and undertake training of new and existing personnel as required
  •  Contribute substantially to the interpretation of data and subsequent impact to methods/product (e.g., participation in statistical process control (SPC), control charting/trending, etc.).

Skills and Requirements:

  • MS or PhD. in Chemistry, Biochemistry, Pharmacology or related discipline.  Advanced degree preferred.
  •  4+ years of relevant experience in a stability related function.  Previous Quality Control / GMP experience is highly preferred.
  • Preferred - experience with HPLC and physico-chemical test methods of oligonucleotides.  Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.
  • Strong skills in the application of statistical methods. 
  • Direct involvement in material specification setting and justification is preferred. 
  • Experience working at a multi-site company and/or with CMOs is helpful

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at +(1) 215-531-6914 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.