Scientist, Analytical Sciences - LC-MS

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 117,000 - 158,200; Full time

Job summary

Alnylam Pharmaceuticals, Inc. seeks a Scientist, Analytical Sciences to join the Impurity Characterization team in Cambridge, MA.

The role focuses on developing and implementing advanced LC-MS workflows for impurity profiling of siRNA therapeutics, collaborating across stability, CMC, and early development groups. The candidate will lead method development using UHPLC-HRMS, drive platform improvements, and contribute to regulatory documents while maintaining hands-on expertise in chromatography

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry or related disciplines with a minimum of 2 years of relevant experience.
• Hands on experience developing UHPLC-high resolution mass spectrometric methods using design of experiments. Experience with oligonucleotide based LC-assay method development, qualification, transfer and troubleshooting strongly preferred.
• Working knowledge of multidimensional LC-MS strongly preferred
• Good documentation and communication skills within the organization and with external partners (contract manufacturing organizations, contract testing labs, external business partners).
• Familiarity with analytical and preparative liquid chromatography hardware and chromatography data software from Waters (Empower, Masslynx, UNIFI) and Agilent (Openlab and Masshunter).

Responsibilities

• Responsible for the development, qualification, scale up and transfer of HPLC based assays for mass and structural identification, characterization, and impurity determination of siRNA therapeutics and their formulations.
• Independently support impurity characterization as an SME by fully understanding all required technical process unit operations and decision making processes to efficiently support full and targeted impurity characterization for program teams as well as forced degradation studies for developmental stability.
• Develop new strategies to improve the overall impurity profiling of new development candidates and raw materials.
• Conceive and implement innovative platform improvements by deployment of novel workflows to increase operational efficiency by leveraging automation.
• Author development reports and regulatory filing documents and manage analytical activities internally and externally.
• Maintain a current working knowledge of HPLC and MS fundamentals in support of troubleshooting of hardware and software.
• Represent the analytical sciences function in cross-functional early stage development by serving as analytical development program representative (backup / lead) for early stage programs.

Skills

UHPLC-HRMS

Oligonucleotide LC‑assays

LC-MS proficiency

Documentation skills

External collaborator liaison

Education

PhD in Analytical Chemistry or Biochemistry

Tools

Waters Empower

MassLynx

UNIFI

Openlab/MassHunter

Job description

Overview:

The Scientist, Analytical Sciences will be a key team member of the Impurity Characterization team contributing to development and implementation of new strategic analytical technologies. A strong candidate will work with single and multidimensional liquid chromatography techniques coupled with mass spectrometry in support of impurity characterization of siRNA therapeutics. They will have direct collaboration with associated functions including stability sciences, process development, CMC project management, and various research and early development functions.

This position is onsite and will be primarily located in Cambridge, MA at our Kendall Square offices.

Responsibilities:

• Responsible for the development, qualification, scale up and transfer of HPLC based assays for mass and structural identification, characterization, and impurity determination of siRNA therapeutics and their formulations.


• Independently support impurity characterization as an SME by fully understanding all required technical process unit operations and decision making processes to efficiently support full and targeted impurity characterization for program teams as well as forced degradation studies for developmental stability.


• Develop new strategies to improve the overall impurity profiling of new development candidates and raw materials.


• Conceive and implement innovative platform improvements by deployment of novel workflows to increase operational efficiency by leveraging automation.


• Author development reports and regulatory filing documents and manage analytical activities internally and externally.


• Maintain a current working knowledge of HPLC and MS fundamentals in support of troubleshooting of hardware and software.


• Represent the analytical sciences function in cross-functional early stage development by serving as analytical development program representative (backup / lead) for early stage programs.

Qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry or related disciplines with a minimum of 2 years of relevant experience.


• Hands on experience developing UHPLC-high resolution mass spectrometric methods using design of experiments. Experience with oligonucleotide based LC-assay method development, qualification, transfer and troubleshooting strongly preferred.


• Working knowledge of multidimensional LC-MS strongly preferred


• Good documentation and communication skills within the organization and with external partners (contract manufacturing organizations, contract testing labs, external business partners).


• Familiarity with analytical and preparative liquid chromatography hardware and chromatography data software from Waters (Empower, Masslynx, UNIFI) and Agilent (Openlab and Masshunter).

#LI-KB1 #LI-Onsite

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

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.