Scientist, Analytical Sciences

Overview:

The successful candidate will be responsible for supporting clinical-stage programs within Analytical Sciences at Alnylam Pharmaceuticals. Responsibilities will include the development, qualification, and transfer of analytical assays to GMP testing labs, authoring of regulatory documents, as well as participating in cross-functional CMC program teams. The successful candidate will also be responsible for technical review of analytical GMP release data and methods/data/protocols/reports generated by internal and external laboratories to support early stage clinical programs. The candidate will be expected to help drive initiatives to enhance the technical capabilities of the group as well as develop streamlined workflows to increase efficiency. Experience in analytical method development of HPLC/UPLC/LCMS/GC-based methods is highly desired.

This position is onsite and will be primarily located in Cambridge, MA.

Responsibilities:

• Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of oligonucleotides, siRNAs, and their formulations, as well as raw material related analytical methods and other methods as needed.
• Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
• Provide analytical support for investigations leading by quality, manufacturing, supply chain.
• Perform testing of late development siRNA candidates and their formulations for their characterization.
• Author method development and qualification reports and SOPs for test methods. Evaluate suitability of new methods and oversee method qualification and validation in the external contract testing labs.
• Author and review analytical sections in regulatory submission documents.
• Apply strong technical knowledge of organic and analytical chemistry to support laboratory investigations (deviations/OOS/OOT), as needed.
• May serve as a primary contact person for cross-departmental needs or projects and be accountable for key deliverables.
• Contribute to the development and/or improvement of technical capabilities as well as initiatives to improve department efficiency.

Qualifications:

• PhD in Chemistry, Biochemistry or related disciplines with relevant industry experience preferred, or Master’s degree with minimum 5 years related industry experience or Bachelor’s degree with minimum 8 years related industry experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.
• Experience with HPLC/UPLC and LCMS-based analytical method development desired.
• Hands-on experience with oligonucleotides is a plus.
• Familiarity with instrument troubleshooting and software including Empower, MassHunter, and UNIFI preferred.
• Knowledge of GxP requirements and application of statistical methods in the analytical laboratory is a plus.
• Strong interpersonal skills, communication, and collaboration.

U.S. Pay Range

$114,100.00 - $154,300.00

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

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel 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.