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Sanofi Group R&D Production Manager & Outsourcing Lead in Framingham, Massachusetts

Position Overview:

The Clinical Injectables Manufacturing organization resides within Sanofi Research & Development and is responsible for producing Phase 1 and 2 clinical drug products. We are looking for a Production Manager to supervise the fill/finish and inspection processes for final drug product vials and syringes. This role will also be responsible for leading outsourcing activities both internally and externally (CMOs). A key aspect for this role is timely delivery to meet projects needs and required quality level per industry regulations and Sanofi standards.

Key Responsibilities:

  • Supervise preparation and running of line for vial and syringe filling operations and final drug product inspection.

  • Tech transfer from formulation development teams and to commercial sites, including phase III under R&D responsibility.

  • Active team member in the Drug Product sub teams and Transfer Teams representing GMP manufacturing.

  • Manage activities of technicians in compliance with standard operating procedures (SOPs).

  • Assure compliance with cGMP requirements (current good manufacturing practices).

  • Complete and review associated production records.

  • Responsible for manufacturing schedule including APS, maintenance shutdowns, preventative and curative maintenance, initial and periodic qualifications (personnel, equipment, environment, utilities) and calibrations.

  • Management of all GMP documents related to manufacture (preparation of master batch record, review of executed batch record, contribution to transfer documents, preparation of technical conditions, writing of risk analysis.

  • Supply of materials and logistics: contribution to harmonization across CIM sites and Sanofi and to definition of best ways of working practices and ensuring implementation, utilizing an SAP system.

Basic Qualifications:

  • Bachelor's degree in Engineering, Biology or related Life Sciences discipline with a minimum of 6 years of experience in cGMP manufacturing environment or a Master's degree and 4 years of experience.

  • A minimum of 3 years of experience managing direct reports.

  • Experience with fill and finish of liquid and lyophilized vials.

  • Final drug product visual inspection experience.

  • Experience with transfer of process both internally and externally.

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

  • Ability to interface with external and internal groups (Formulation, Bioanalysis, QA, QC, Validation, Engineering, Clinical Supply Chain, other CIM teams, IA, MSAT and Vendors).

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

  • Excellent communication and organizational skills.

  • Self-motivated and detailed oriented.

Preferred Qualifications:

  • Previous experience with fully automated filling equipment.

  • Formulation development/pharmaceutical engineering/process development/commercial production/management of outsourcing/data sciences knowledge.

  • Experience with fill and finish of syringes.

  • Experience starting up a new facility.

Special Working Conditions

  • Schedule is Monday-Friday, first shift. Occasional second shift and weekend work is required.

  • Lift up to 50 pounds.

  • Push/pull up to 50 pounds to move loaded, wheeled carts with assistance from another worker.

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

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

  • Frequent reaching between waist and shoulder level.

  • Occasional reaching up and out.

  • Repetitive grasping and movement of hands and fingers.

  • May involve work with hazardous materials.

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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