Stability Scientist – Analytical Sciences (siRNA/GMP)

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 117,000 - 158,200; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with company match

Paid time off

Job summary

Alnylam Pharmaceuticals is seeking a Scientist, Analytical Sciences to support stability programs for siRNA substances and products. The role is onsite in Cambridge, MA, with responsibilities spanning plan development, data analysis, and regulatory documentation.

The candidate will contribute to regulatory submissions, data interpretation, and collaboration across multiple sites and CMOs. A strong background in HPLC and stability methods is required.

Qualifications

• MS or PhD in Chemistry, Biochemistry, Pharmacology or related discipline; advanced degree preferred.
• Minimum 4 years of stability-related experience; GMP/Quality Control experience preferred.
• Experience with HPLC and physicochemical test methods of oligonucleotides (or oligosaccharides/proteins).
• Strong skills in the application of statistical methods.
• 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 agency responses.
• Manage stability deviation and out of trend process.
• Assist in deriving stability specifications and provide stability expertise for risk assessment.
• Contribute to interpretation of data and impact to methods/products (e.g., SPC, control charting/trending).
• Support general lab operations including data review and documentation; provide technical support to Quality.

Skills

Statistical methods

Education

MS/PhD in Chemistry/Biochemistry/Pharmacology

Tools

HPLC

Job description

Alnylam Pharmaceuticals is seeking a Scientist, Analytical Sciences to support stability programs for siRNA substances and products. The role is onsite in Cambridge, MA, with responsibilities spanning plan development, data analysis, and regulatory documentation.

The candidate will contribute to regulatory submissions, data interpretation, and collaboration across multiple sites and CMOs. A strong background in HPLC and stability methods is required.