Senior Research Associate Analytical Development

Job Title: Senior Research Associate Analytical Development

Grade: L1
Hiring Manager: He Meng

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

Join our state-of-the-art AD/QC lab as a Senior Research Associate, and you’ll assure the safety, quality, purity, and stability of Sanofi components and products, while enjoying numerous opportunities to broaden your experience and hone your skills.

We are looking for a highly motivated individual with expertise in physicochemical method development to join the Analytical Development and Quality Control group, part of the Global CMC Development organization at Sanofi, Framingham, MA. The Analytical Development group has the overall responsibility to establish phase-appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of protein drug candidates. In addition, the Analytical Development group performs cGMP-compliant sample testing for the purpose of drug substance and drug product lot release and stability testing. The goal of all these activities is to enable rapid progression of multiple therapeutic candidates into the clinic.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Independently perform GMP and non-GMP sample testing according to method protocols (SOPs) and document results in an electronic lab notebook or data packets.

• Contribute to analytical method development, qualification, validation, and transfer. Support lab investigations and troubleshooting of methods as needed.

• Perform various separation science platforms such as HPLC/UPLC (Size exclusion chromatography, Ion exchange chromatography, reversed phase HPLC, and Hydrophilic Interaction Chromatography (HILIC)), using a variety of detection modes including mass spectrometry. In addition, the individual may support other analytical methodologies such as capillary electrophoresis, binding assays, and/or methods used for biologics (mAbs, bispecific and trispecific antibodies, and fusion proteins) depending on project needs.

• Draft method protocols, assay qualification and validation plans/reports, and ensure that the documents adhere to GxP requirements and ICH guidelines.

• Maintain a GMP compliant laboratory environment.

• Oversee routine preventive maintenance of HPLC/UPLC instruments.

• Ensure timely completion and delivery of analytical results and documentation (ELN, technical reports, SOPs, etc.).

About You

Basic qualifications

• Bachelor’s degree in Biochemistry, Analytical Chemistry, or related discipline with a minimum of 2 years of relevant experience in the biotechnology/pharmaceutical industry or a master’s degree with 0-2 years of relevant experience.

Preferred Qualifications

• Experience in HPLC separation methods and use of HPLC instruments. Knowledge of electrophoresis (e.g. capillary electrophoresis, cIEF), binding assays and/or spectrophotometric assays would be beneficial for the position.

• Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations and deviations) will be considered an advantage.

• Experience with OpenLab and Empower CDS, and iLab will be a plus.