Stability Specialist - Contract - Cambridge, MA
Safeguarding the stability behind next‑generation RNA therapies.
Proclinical is seeking a Stability Contractor will be responsible for stability support of siRNA drug substances, drug products, intermediates, and critical raw materials.
Primary Responsibilities:
The successful candidate will be a major contributor of data to the CMC sections of regulatory filings, and you will provide inter-departmental support by ensuring continuous supply and life-cycle management of stability programs internally and at contract manufacturers/laboratories.
Skills & 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.
- Hands-on experience in writing stability reports, analyzing stability data, and conducting stability data trending
- Experience with HPLC and physico-chemical test methods of oligonucleotides is highly preferred. Alternatively, experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.
- Strong skills in the application of statistical methods, experience with JMP
- Direct involvement in material specification setting and justification is preferred.
- Experience working at a multi-site company and/or with CMO/CTLs is helpful
The Stability Specialist's responsibilities will be:
- Organize the stability testing program for specified developmental and clinical 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 the plan and act where targets could be missed.
- Prepare a stability plan with stakeholders.
- Author and review stability SOPs and protocols in accordance with company and regulatory guidelines.
- Review, analyze, and trend stability data, and assist in deriving stability specifications.
- Provide stability expertise to the 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.
- Contribute to stability deviation and out-of-trend process.
- 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.).
- Expected contributions to general laboratory operations, including review of data, authorship/review of technical documentation, and inspection readiness. Provide QC technical support as needed.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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