*Hours 7PM-7AM- rotating
The Upstream Operation Department performs small and large scale cell culture operations, equipment preparation, clean in place (CIP) and steam in place (SIP) of process equipment and the preparation/operation of microfiltration systems in our Allston Landing Manufacturing Plant.
POSITION OVERVIEW/KEY RESPONSIBILTIES:
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.
· Buffer formulation
· Demonstrating general knowledge of buffer formulation
· Use of benchtop equipment (pH, conductivity, refractometer, osmometer)
· Capture Operations
· Demonstrating general knowledge of chromatography columns
· General knowledge of microfiltration operations
· All Teams
· Demonstrating general knowledge of aseptic techniques
· Strict adherence to SOPs
· Performing CIP and SIP operations to prepare equipment for manufacturing operations.
· Operating autoclaves and glassware washers
· Effectively demonstrates understanding of GMPs & how it applies to specific responsibilities.
· Following accurate oral & written procedures in operating production equipment & performing processing steps
· Maintaining orderliness of process area
· Stocking production area with supplies
· Monitoring operations to ensure compliance with process specifications
· Practices safe work habits and adheres to Sanofi's safety procedures and guidelines.
· Trains new employees
· Utilizes manufacturing knowledge to improve process operations and affect positive change.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
· High School Diploma/GED with 2-4 years of experience in cGXP manufacturing environment, or Bachelor's Degree with 1-3 years of experience.
· Bachelor's degree with 1-3 years of experience in bulk biologics cGMP manufacturing.
· Effectively uses process automation systems to operate production processes (i.e. Delta V).
· Experience in reviewing and creating controlled documents.
· Familiarity with Deviation Management Systems (i.e. TrackWise).
SPECIAL WORKING CONDITIONS:
· Ability to lift up to 40 lbs
· Ability to stand for 6 hours in a production suite.
· Ability to gown and gain entry to manufacturing areas
· Ability to work a 12 hour rotating shift and every other weekend, including holidays as scheduled.
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.