Department Description: The Clinical Trial Manufacturing team has a full-time opportunity for an individual to perform mammalian cell culture manufacturing processes in a pilot facility in a regulated cGMP environment. Reporting into the Manufacturing Manager, this group is part of the Sanofi Biologics Development Drug Substance Manufacturing organization based in Framingham, Massachusetts. This role requires weekend work on a rotating basis.
Perform thawing and expansion of cultures in shake flasks and small-scale disposable bioreactors
Preparation, inoculation and sampling of pilot scale bioreactors
Perform Preventative Maintenance (PMs) and basic troubleshooting.
Participate in clinical manufacturing under cGMP regulations which includes sampling, analyzing, documenting, witnessing production events, and equipment reprocessing.
Operate complex systems and equipment using batch records and SOPs in accordance with current GMPs and safety guidelines under limited supervision.
Associates degree or High school diploma/GED or Biotechnology certificate with a minimum of 3 years' experience in cGMP cell culture environment
Large-scale or small-scale bioreactor production experience.
Candidates should demonstrate good technical writing skills, good troubleshooting skills, strong attention-to-detail and developed communication skills.
Ability to lift 30 pounds.
Must be available for weekend and holiday work, as required.
Experience with Mammalian cell culture cGMP manufacturing
Experience with bacteria or yeast culture using similar equipment and SOP's
Experience with the use of cell culture analyzers
Experience working with automated control systems (Delta V or equivalent) and single-use technology.
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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