Manager, Pathology Lab

Custom Field 1: 1845

Date: Jul 9, 2025

Location:

Cambridge, MA, US, 02142

Summary

The successful candidate will be responsible for supporting clinical-stage programs within Analytical Development at Alnylam Pharmaceuticals. This position will report to the Associate Director of CMC Analytical Operation sub-team. Responsibilities will include development and qualification of purity and impurity methods for Alnylam’s platform siRNA assets, transfer of analytical assays to GMP testing labs, manufacturing investigation support, authoring regulatory filing and responding to Health Authorities questions pertaining to analytical methods, as well as representing Analytical Development 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 also 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 and qualification of HPLC/UPLC/LCMS/GC-based methods, and a good understanding of Regulatory Guidelines are highly desired. Prior
experience in technical oversight of outsourced analytical work would be an added advantage. Must be initiative-taking and collaborative, have a demonstrated ability to deliver innovative solutions, and be able to work in a fast-paced and deadline-driven environment and be flexible to deal with changing priorities.

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

Job Description

Key Responsibilities

Represent Analytical Development in cross-functional CMC program teams and serve as a primary contact person for cross-departmental needs or projects.
Author analytical sections in regulatory submission documents and respond to questions from the Health Authorities around the world.
Apply strong technical knowledge of organic and analytical chemistry to support laboratory and manufacture investigations (deviations/OOS/OOT).
Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of platform siRNA molecules, and their formulations. Author method development and qualification reports and SOPs for test methods.
Lead analytical testing and impurity identification and characterization on late development siRNA assets.
Oversee method transfer and validation in the external contract testing labs.
Contribute to the development and/or improvement of technical capabilities within Analytical Development as well as initiatives to improve department efficiency.

Qualifications

PhD in Chemistry, Analytical Chemistry, or related discipline.
8+ years industrial experience
Strong technical background and direct experience with HPLC/UPLC and LCMS-based analytical method development and qualification/validation. Experience with oligonucleotides is preferred.
Familiarity with cGMP, ICH, and regulatory guidelines. Prior experience in GMP and Regulatory settings a plus.
Experience with instrument troubleshooting and software including Empower, MassHunter, and UNIFI.
Knowledge of GxP requirements and application of statistical methods in the analytical laboratory.
Strong interpersonal skills, communication, and collaboration within and outside of the organization.
Ability to adjust to changing priorities in a dynamic environment.

Key Skills and Compentencies

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.