Senior Associate Scientist (Bioassay Development)

Sanofi•Framingham, MA

2d•Onsite

About The Position

Sanofi is seeking a highly motivated Senior Associate Scientist (Bioassay Development) to join the Analytical Development team within Mammalian Bioanalytics. This team develops, validates, and transfers analytical methods used for characterization and release of biologics to support the clinical development of new medicines. The successful candidate will participate in the development and validation of analytical methods involving qPCR, ELISA, MSD, cell-based assays, and other analytical techniques routinely used to support biotherapeutics development. This individual will conduct pre-clinical and clinical lot release and stability testing of biotherapeutics, including antibodies, antibody-like molecules, enzymes, and other therapeutics. This role operates within a cGMP environment and requires excellent verbal and written communication skills, strong attention to detail, and the ability to collaborate effectively with cross-functional departments. Sanofi is an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. It's a place where employees can flourish and grow their careers, with countless opportunities to explore, make connections, and stretch the limits of what they thought was possible.

Requirements

B.S. degree in Biology, Biochemistry, Immunology, Biotechnology, or related life sciences discipline with a minimum of 1 year of relevant experience.
An understanding of Biology, Biochemistry, Biophysical methods.
Must be organized, efficient, and able to work according to timelines.
Excellent organizational and communication skills.
Must be able to work collaboratively in a fast-paced, team-oriented environment.
Must have permanent US work authorization.

Responsibilities

Participate in the development, qualification, validation, and transfer of qPCR, ELISA, MSD, cell-based assays and potentially other analytical methods in a regulated GMP environment.
Perform routine cell culture activities such as thawing, passaging and banking cells.
Cross train in separation techniques such as cIEF, CE-SDS and SEC and support GMP release and stability testing as needed.
Perform cGMP sample testing according to standard operating procedures (SOPs) and compile data packets.
Assist in the drafting of SOPs and technical reports and be able to effectively communicate progress and experimental results to supervisor and team members.
Support Analytical equipment maintenance by performing regular scheduled activities to comply with GMP standards to maintain a GMP compliant laboratory.
Ensure timely completion and delivery of all analytical results and documentation (technical reports, SOPs, ELN, LIMS, etc.) to support product development during clinical phases.