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Sanofi Group R&D Manufacturing Specialist Down Stream Processing in Framingham, Massachusetts

Position Overview:

This is a R&D manufacturing specialist position in the Framingham Drug Substance Manufacturing Biologics (DSMB) group focusing on Down Stream Processing (DSP). This group is responsible for producing Phase 1 through early Phase 3 clinical dug substance to support first in human and later stage clinical trials. The main role for this position will be leading the downstream steps processing harvest from the bioreactor through to drug substance (Purification operations).

Key Responsibilities:

  • Lead the process team in daily manufacturing activities.

  • Coordinate the daily process schedule to ensure the daily processing is performed.

  • Ensure all necessary materials/supplies are staged for processing.

  • Perform daily process activities in compliance with standard operating procedures (SOPs) and execution of batch documents.

  • Operate downstream process equipment and operations in compliance with cGMP requirements (current good manufacturing practices).

  • Column chromatography

  • Virus filtration

  • Ultrafiltration/Diafiltration

  • Adjustment of intermediates

  • Other purification processing steps as needed.

  • Revise production batch records and appropriate SOPs.

  • Prepare equipment and solutions for processing.

  • Complete and review associated production records.

  • Complete cGMP documentation and logs.

  • Interact with validation, metrology, and facilities groups to ensure equipment is maintained in cGMP status.

  • Prepare and submit samples for QC and other testing to the analytical laboratories.

  • Interact with QA when compliance issues arise.

  • Support activities include maintaining supplies, preparing solutions, setting up and disassembling processing equipment cleaning and maintaining equipment, basic troubleshooting.

  • Follow safety and compliance procedures including training and ALCOA principles.

  • Participate on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative Action.

  • Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive changes.

  • Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.

  • Perform training with staff on the floor, as needed.

  • Schedule is Monday-Friday, first shift. Occasional weekend work may be required.

Basic Qualifications:

  • High School diploma/GED, Biotechnology certificate or Associates degree in biology/chemistry with a minimum of 5 years of experience in cGMP manufacturing environment or a Bachelor's degree in biology/chemistry or a related discipline with a minimum of 3 years of experience in cGMP manufacturing environment.

  • Understanding of chromatography, membrane filtration and other unit operations used in protein purification.

  • Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

  • The ability to cooperate with others in a team environment.

  • SOP writing.

  • Must have permanent US work authorization

Preferred Qualifications:

  • Proficiency in aseptic technique.

  • Experience using Unicorn AKTA skid or other manufacturing systems.

  • Experience with Athena or similar SAP system.

  • Must be self-motivated, detailed oriented, have good time management skills, be flexible, team oriented, and demonstrate good troubleshooting skills.

Special Working Conditions:

  • Ability to gown and work in clean room environment.

  • Ability to lift 50 pounds.

  • Push/pull up to 50 pounds to move mobile equipment around the process suites.

  • Frequent sitting, walking, standing, bending and squatting.

  • May require standing and walking up to 70% of day.

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 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.

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.

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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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