Sanofi Group Global Head (m/f) Clinical Drug Product Manufacturing in Framingham, Massachusetts

Generic

Sanofi tirelessly continues on its path towards becoming a world-class biologics organization and it is expanding the capabilities in this area. Biologics Development, responsible for all aspects of biologics CMC, is a key enabler in this ambition through its mission to develop manufacturing processes, formulations, and analytical methods as well as to scale up and manufacture clinical trial material. Developing new and disruptive technologies is our passion.

The Global Head of Clinical Drug Product Manufacturing will report to the Global Head of Biologics Development and will lead a network of three clinical parenteral drug product manufacturing facilities situated in Vitry, France, Frankfurt, Germany and Framingham, USA. She/he will be responsible for the manufacturing of clinical parenteral drug products for all modalities within the Sanofi R&D portfolio, and will collaborate closely with the Global Head of Biologics Drug Product Development.

Key Responsibilities

  • Responsible for the production of clinical parenteral drug products for all modalities (biologics and small molecules) within the Sanofi R&D portfolio

  • Through direct supervision of plant heads, of the three clinical DP manufacturing facilities ensure cGMP compliance – including, but not limited to, equipment validation, media fills, document management, staff training and maintainence of training records, document management, deviation / CAPA management and change control management.

  • Ensuring expedient and thorough resolution of investigations of manufacturing deviations with timely implementation of associated CAPAs

  • Responsible for crafting and executing the global clinical parenteral DP manufacturing schedule with appropriate prioritization per R&D projects demands.

  • Developing and maintaining a strong working relationship with site and global quality operations as well as IA injectable launch units

  • Develop and maintain a harmonized manufacturing network in terms of:Standard operating proceduresProduction records (with allowance for language translations as appropriate)Media fill validation strategiesEquipment/qualification/validation strategies and practicesUse of disposable materials, chemicals, and excipientsPrimary packaging, and for storage, and shipping of manufactured unitVisual inspection methodologies

Requirements & Qualification

Education / Experience

Education: Chemical Engineering, Pharmaceutical Sciences, Biochemistry or a related discipline

Experience:

  • BS with 15 years of experince, MS with 12years, or a PhD with 10 years of experience

  • The experience must be relevant to the role and should include manufacture of biologics, including liquid/lyophilized product, in vials/syringes.

  • At least 7 years of experience in GMP, parenteral, drug product manufacturing.

  • Experience leading manufacturing operations. Managerial experience with multi-cultural influencing/leadership preferred

Technical skills & Competencies / Language

  • Direct experience in managing a parenteral cGMP manufacturing facility and experience in production of multiple presentation formats (vials (liquid and lyo), prefilled syringes, cartridges)

  • Prior experience/exposure to Biologics/parenteral drug product development

  • People-management skills with a demonstrated record of operational excellence in a GMP environment

Behavioural Competencies

  • Lead and work in a multi-cultural professional environment

  • Be execution oriented on delivering organizational objectives

  • Foster a culture of technical excellence and collaboration; ensure operational excellence in execution

  • Be able to navigate across a complex organization, possess an ability to form collaborative networks within and with partner organizations

Our offer:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).

  • An individual and well-structured introduction and training of new employees.

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well.

#LI-GSA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life