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