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Production Manager Clinical Injectables Manufacturing

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: June 7, 2021

Job Description:

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 and production of our final drug product vials and syringes for both internal and external manufacture. 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:

  • Participate in the start-up activities for a new Fill and Finish facility located in Framingham, Massachusetts, including autoclave, parts washer, inspection system, lyophilizer, and automated filling line under isolator.

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

  • 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.

  • Transfer from formulation development teams and to IA, including phase III under R&D responsibility and being a team member in the projects Drug Product sub teams and Transfer Teams representing GMP manufacturing.

  • 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.

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.

  • 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.

  • 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.

  • Must be self-motivated and detail-oriented.

Preferred Qualifications:

  • Previous experience with fully automated filling equipment.

  • Formulation development/pharmaceutical engineering/process development/commercial production/management of outsourcing/data sciences knowledge could be in the preferred qualifications.

  • 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.




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.

Keywords: Principia Biopharma Inc., Framingham , Production Manager Clinical Injectables Manufacturing, Other , Framingham, Massachusetts

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