Stability Specialist

Job Description

Responsibilities:

• The Contractor, Stability will be responsible for stability support of siRNA drug substances, drug products, intermediates and critical raw materials.
• Major contributor of data to CMC sections of regulatory filings.
• Provide inter-departmental support by ensuring continuous supply and life-cycle management of stability programs internally and at contract manufacturers/laboratories.
• 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 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.
• Review, 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.
• 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.

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.
• 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 CMO/CTLs is helpful
• Strong verbal and written communication skills, including the ability to present stability data cross-functionally.