Overview: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.
This position is onsite and will be primarily located in Cambridge, MA.
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.
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.
U.S. Pay Range$117,000.00 - $158,200.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
