Sanofi Group Senior Manufacturing Associate, Lab Operations in Framingham, Massachusetts
We are seeking a highly motivated individual to join the BioProcess Engineering (BPE) department, part of the Sanofi Global CMC Development organization, in the role of Senior Manufacturing Associate. This role is accountable for leading a team within the Lab Operation group in the production of medium and buffers to support Pilot and small-scale development production. The role will supervise the operation of the process lab equipment and the production of medium/buffers based on the process schedule. The role will support BioProcess development USP/DSP, Cell Technology, Cell Line Development and Technical Pilot Plant at 31NYA.
The schedule is Monday-Friday 8 hours day shift, 7:00am – 3:30pm
Operation of Lab equipment in strict accordance with SOP’s in support of cell culture and purification operations.
Coordination of Metrology and servicing of Lab Operations manufacturing equipment.
Perform Component Weighing, batching of media and buffer, sterile filtration and aseptic technique in a cGLP manufacturing facility.
Lead routine production of media and buffer at 50L – 2000L scale.
Perform Clean In Place (CIP) for media preparation tanks.
Perform the set-up of process equipment.
Review of document records for completeness and accuracy.
Operate complex systems and equipment in strict accordance with SOP's, and safety guidelines.
Implementation of production procedures to optimize manufacturing processes.
Participate in plant trials for evaluating process modifications.
Provide training to new personnel in all areas of the Lab Operations activities.
Troubleshoot processing problems.
Maintain all associated documentation for operations being performed.
Accurately complete batch records and logs sheets.
Monitor and maintain laboratory equipment operation.
High School/GED with a minimum of 5 years of relevant experience with cGLPs/GMPs in biotech or pharmaceutical industry or an Associate's degree with a minimum of 4 years or a Bachelor's degree with a minimum of 3 years of relevant experience
A minimum of 2 years’ experience with buffer, media and equipment preparation
Ability to lift 50+ pounds.
Preferred Qualifications :
Ability to handle multiple tasks simultaneously.
Experience reviewing and creating documents
Strong attention to detail.
Self-motivated and have excellent organization, communication and computer skills.
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.