Sanofi Group Production Technician USP in Pearl River, New York
Primary responsibility is bench- and bioreactor- scale cell culture and recombinant protein production operations for commercial production through execution of SOPs, Batch Records, and all associated cGMP activities in the manufacturing facility. Duties include operation, maintenance, cleaning (CIP) and sterilization (SIP) of large scale cell culture bioreactors, associated operations such as media preparation and harvest, as well as bench- and 100L bioreactor- scale cell culture and virus stock preparation, working cell stock vial thaw, cleaning and maintenance of process equipment, and preparation and formulation of media components. The incumbent is capable of identifying, troubleshooting and leading the resolution of operational and equipment problems as they arise in the Bioreactor, Media Preparation and Cell Culture areas with minimal supervision and effective communication to management. Incumbent will enter and trend data in process spreadsheets, lead or support the updating of existing or new batch records for current or new processes, initiation of change controls, deviations and the closing of these documents. Leads the training of junior personnel within the Bioreactor, Media production and Cell Culture areas. May include cross training to support other areas as needed.
In depth understanding of aseptic technique / cell culture techniques and processes being executed on routine basis.
Understanding of the BEVS manufacturing process.
Use and maintenance of equipment including biosafety cabinets, incubators, tabletop centrifuge, microscope, automated cell counter, 100L bioreactor, tubing welder and sealer, peristaltic pump, 30L, 300L and 2000L bioreactors.
Ability to manage and analyze manufacturing data to identify and support changes and improvements.
Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
Ability to present and explain techniques and results of manufacturing processes with outside departmental personnel.
Responsible for identifying required training and training on, understanding, and following documented procedures which apply to their departments that support the Quality System.
Maintains records and documentation in accordance with a cGMP environment and improves as necessary.
Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
Cross training as a support operator as required.
Follows established SOPs for the flow of materials, personnel and equipment in and out of the cGMP facility
Follows instructions on notification of deviations as they occur and provides information during investigations.
Other duties as they are required.
Education: High School degree with at least 5-7 years' experience or training in a cGMP manufacturing environment OR BS degree with 3-5 years' of work experience OR MS degree with 1-3 years' work experience.
Knowledge of cGMP.
English fluent, both written and spoken.
Good communication and social skills.
MS Word and Excel proficiency preferred but not required.
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.