Stability Scientist job in Cambridge, USA

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Job type: Contract

Discipline: Biological Sciences, Medicinal Chemistry, Pharmacokineticists

Location: United States

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.

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Author and review stability reports.
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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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