Scientist, Analytical Sciences - Stability

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

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 - $158,200.00

The 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

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.