Scientist, Analytical Sciences

Overview:

The Scientist, Analytical Sciences will be responsible for stability support of siRNA drug substances, drug products, intermediates and critical raw materials. In addition, the role will be a major contributor of data to CMC sections of regulatory filings and provide inter-departmental support by ensuring continuous supply and life-cycle management of stability programs internally and at contract manufacturers.

This position isonsite and will be located at our Kendall Square offices in Cambridge, MA.

Responsibilities:

• 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.
• 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.).
• Expected contributions to general laboratory operations including review of data, authorship/review of technical documentation, and inspection readiness. Provide QC technical support as needed.

Qualifications:

• 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 physicochemical test methods of oligonucleotides. Alternatively - experience with HPLC and physicochemical 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.