Scientist, Analytical Sciences, Stability

Alnylam Pharmaceuticals•Cambridge, MA

1d•$117,000 - $158,200•Onsite

About The Position

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

Requirements

MS or PhD. in Chemistry, Biochemistry, Pharmacology or related discipline.
Minimum 4 years of relevant experience in a stability related function.
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.

Nice To Haves

Advanced degree preferred.
Previous Quality Control / GMP experience is highly preferred.
Experience working at a multi-site company and/or with CMOs is helpful.

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. Assist with responses to agency requests.
Manage stability deviation and out of trend process.
Assist in deriving stability specifications. Provide stability expertise for the risk assessment 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 technical support to Quality group as needed.