Scientist, Analytical Sciences - Stability
Alnylam Pharmaceuticals
August 11, 2026
On-site
Cambridge, MA
Operations
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 per 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 deviations and out-of-trend process.
- Assist in deriving stability specifications; provide stability expertise for risk assessment.
- Interpret data and assess impact to methods/product (e.g., SPC, control charting/trending).
- Support general laboratory operations: review data, author/review technical documentation, support inspection readiness; provide technical support to Quality as needed.
Qualifications:
- MS or PhD in Chemistry, Biochemistry, Pharmacology, or related discipline; advanced degree preferred.
- 4+ years relevant stability experience; prior Quality Control/GMP experience highly preferred.
- Highly preferred: HPLC and physicochemical test methods of oligonucleotides; alternatively, oligosaccharides or proteins.
- Strong statistical methods skills.
- Helpful: experience at multi-site companies and/or with CMOs.
Benefits/Pay (if applicable in posting):
- Base pay range: $117,000.00–$158,200.00; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, and vision; life/disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Application instructions: Learn more about additional benefits at https://www.alnylam.com/careers.
- 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 per 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 deviations and out-of-trend process.
- Assist in deriving stability specifications; provide stability expertise for risk assessment.
- Interpret data and assess impact to methods/product (e.g., SPC, control charting/trending).
- Support general laboratory operations: review data, author/review technical documentation, support inspection readiness; provide technical support to Quality as needed.
Qualifications:
- MS or PhD in Chemistry, Biochemistry, Pharmacology, or related discipline; advanced degree preferred.
- 4+ years relevant stability experience; prior Quality Control/GMP experience highly preferred.
- Highly preferred: HPLC and physicochemical test methods of oligonucleotides; alternatively, oligosaccharides or proteins.
- Strong statistical methods skills.
- Helpful: experience at multi-site companies and/or with CMOs.
Benefits/Pay (if applicable in posting):
- Base pay range: $117,000.00–$158,200.00; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, and vision; life/disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Application instructions: Learn more about additional benefits at https://www.alnylam.com/careers.