As part of the Sanofi Biologics Development organization in Framingham, the Drug Substance Manufacturing Biologics (DSMB) group transfers in and implements the cell culture, purification and formulation processes for early stage biotherapeutic clinical product candidates. The group operates clean-room production suites under cGMPs at two sites to produce protein drug substance suitable for use in First in Human and later stage clinical trials. The DSMB group works closely with the Upstream and Downstream process development groups during the transfer of processes into DSMB. DSMB interacts closely with the Quality Assurance (QA) group to ensure cGMPs are maintained.
The candidate for this full-time position will work as part of a team to perform the protein purification manufacturing processes in a multiple product pilot facility in a regulated cGMP environment as follows:
Following good documentation practices and strict adherence to SOPs and batch records is required.
Operate downstream purification equipment for chromatography, nanofiltration and tangential flow filtration.
Support activities include maintaining supplies, preparing solutions, setting up and disassembling processing equipment, cleaning and maintaining equipment, basic troubleshooting.
Interact with the Downstream process development group during the technical transfer of new programs.
Interact with validation, metrology and facilities groups to ensure equipment is maintained for cGMP use.
Submit samples for QC and other testing.
Interact with QA when compliance issues arise.
Participate in revising/writing SOPs and batch records.
High school diploma/GED with a minimum of 5 years of relevant experience in a cGMP environment or Bachelor's degree with a minimum of 1 year of relevant experience.
Ability to work closely with others in a team setting.
Understanding of chromatography, membrane filtration and other unit operations used in protein purification.
Previous experience in a protein purification lab, ideally at pilot scale.
Experience using Unicorn AKTA.
Experience with single use downstream technology.
Proficiency in aseptic technique.
Familiarity with Microsoft Word and Excel.
Special Working Conditions:
Ability to gown and work in clean room environment.
Ability to work flexible hours if needed.
Ability to work in a cold room environment (8 degrees C; 46 degrees F) if the process requires (not typical).
Ability to lift 40 pounds and move mobile equipment around the process suites.
Ability to work standing for extended periods of time.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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