Stability Scientist

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 s.briggs@proclinical.com.

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.

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