LC-MS Impurity Characterization Scientist (siRNA)

Alnylam Pharmaceuticals, Inc.

United States

On-site

USD 117,000 - 158,200

Full time

14 days+

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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.