As part of the Sanofi Biologics Development organization in Framingham, MA, the Drug Substance Manufacturing Biologics (DSMB) Department supports biologics manufacturing activities for early stage biotherapeutic clinical product candidates in a regulated cGMP multi-product pilot facility. The DSMB-Buffer Media Prep (BMP) group performs large-scale buffer and media preparation, equipment preparation, clean-in-place (CIP), and Preventative Maintenance of process equipment in support of upstream (cell culture) and downstream (purification) operations.
This is an upstream position in the DSMB-Buffer Media Prep group with the primary accountability to oversee and participate in a diverse range of clinical manufacturing related activities that involve the weighing of chemicals, preparation of bulk solutions, filling into process containers, and labeling under sterile/non-sterile conditions in a regulated cGMP environment. This includes routine buffer/media preparation, aseptic filtration, setting up and disassembling process equipment, cleaning, autoclaving, maintenance of equipment, maintaining supplies, and basic troubleshooting systems. Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change. Good documentation practices and strict adherence to SOPs and batch production records are required. Authors, reviews, and revises batch records, SOPs, validation documents, and other GMP documentation to meet strict quality guideline. Coordinates and manages the qualification of equipment along with the Validations group.
Additional responsibilities include managing cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action. Leads change control activities for adding new equipment as well as modifying new equipment, materials, and processes as a part on continuous improvement. Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance. Performs training with staff on the floor, as needed. Works independently with minimal supervision and direction.
Schedule: Full-time Monday-Friday, 8 hour day shift. The working schedule for this job position will be an 8 hour shift/5 days a week with an early afternoon start to provide operational flexibility (late start staggered shift). This shift will take effect based on demand and once a team has been established to support these activities.
Preparation of bulk solutions, filling, and labeling under sterile/non-sterile conditions in a regulated cGMP environment. Will supervise on-the-floor activities absence of supervisors.
Oversee and participate in component weighing, batching of buffer and media, sterile/clarification filtration and aseptic technique in a cGMP environment.
Participate in the build, cleaning, autoclaving, of equipment to support large scale buffer/media preparation.
Identify, escalate and document events and variances that deviate from normal operation; participate as needed in investigations.
Maintain cleanliness and orderliness of manufacturing and process area(s).
Maintain production area with supplies.
Oversee the general maintenance and qualification of manufacturing equipment.
Participate in the creation and review of documents including batch production records, manufacturing procedures, and cross functional procedures by providing input to the technical composition of the documents.
Troubleshoot basic mechanical operations or routine processing problems.
Participate in deviation/nonconformance identification and resolution.
May assist in the investigation of deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution. Perform cleaning operations to prepare equipment for manufacturing operations.
Utilize manufacturing knowledge and investigation skill sets to help identify and resolve manufacturing issues, improve process operations, and affect positive change.
Interact/coordinate activities with other support functions, such as Quality Assurance, Quality Control, Manufacturing Engineering, Validation, Metrology and Facilities).
Liaison with Metrology department to ensure equipment is calibrated in a timely manner.
High school diploma/GED or Biotech Certification with a minimum of 7 years of experience in cGXP manufacturing environment, or Bachelor’s degree with a minimum of 5 years of experience.
Knowledge and demonstrated understanding of cGXP and how it applies to specific responsibilities and manufacturing operations.
Minimum of 2 years’ experience with deviation or investigation management systems.
Excellent communication skills
Must have permanent US work authorization
Bachelor’s degree in Biology, Chemistry, Biochemistry or Chemical/biochemical Engineering.
Demonstrated ability to lead cross functional teams and facilitate team meetings.
Experience authoring and reviewing standard operating procedures, on-the-job trainings and other controlled documents.
Familiarity with Deviation Management Systems.
Experience in troubleshooting, investigations and root cause analysis in a GXP environment.
Special Working Conditions:
Will require schedule-dependent late shift work to complete the batching of multiple solutions per day
May involve work with hazardous materials.
May require standing and walking up to 70% of day.
Requires physical demands of bending, stretching, pushing, pulling, and lifting up to 35 pounds.
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.