Scientist, Analytical Sciences, Stability

Responsibilities

• Prepare stability plan with stakeholders.
• Test, analyze, and trend stability data for specified developmental and clinical programs.
• Design and execute compatibility and in-use studies.
• Manage temperature excursions.
• Author and review stability SOPs and protocols in accordance with company and regulatory guidelines.
• Author and review stability reports.
• Author and contribute analytical data to stability sections of regulatory submissions.
• Auxiliary with responses to agency requests.
• Manage stability deviation and out of trend process.
• Auxiliary in deriving stability specifications.
• 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.).
• Provide technical support to Quality group as needed.

Qualifications

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

Pay

$117,000.00 - $158,200.00