Global Head, Biologics Drug Product Development & Manufacturing

Position Overview:

CMC Development, responsible for all aspects of CMC for multiple modalities – synthetic molecules, mammalian and microbially expressed proteins, as well as cell/gene therapy – is a key enabler in Sanofi R&D’s ambition. Our mission is to develop manufacturing processes, formulations, and analytical methods; scale up and manufacture clinical trial material; lead/manage CMC teams, clinical supply/demand management and authoring/coordinating regulatory submissions.

Within CMC Development, the Global Head of Biologics Drug Product Development and Manufacturing will report to the Global Head of CMC Development and be responsible for all aspects of drug product development including developability assessment, formulation development, drug product process development, scale-up/ technology transfer, as well as GMP clinical manufacture and regulatory document authoring; from early engagement with the Biologics Research platform all the way through clinical development leading up to BLA submission and approval. The scope includes all the biologics projects irrespective of the source platform: mammalian, microbial or gene therapy.

Given that the drug product (vials, syringes, auto-injectors) represents the closest CMC gets to the patients, this is an extremely critical role with highest impact on patient convenience. Also, since the formulation design defines the shelf-life of the product, this function also has a lasting impact on the commercial supply chain.

Key Responsibilities:

Deliver Drug Product portfolio in close coordination with other CMC functions (including Mammalian, Microbial and Gene Therapy platforms, project and portfolio management) as well as other functions in R&D (including Research, Clinical, Regulatory Affairs), Industrial Affairs (including Quality, Specialty Care Platform) and GBUs (including Specialty Care).

Specifically, manage the following functions / activities:

• Developability: Develop sophisticated predictive methods to assess the suitability of candidate molecules to progress from Research to Development

• Formulation Development: Develop stable liquid or lyohphilized formulations for clinical or commercial administration with high degree of stability and long (several years) of shelf-life

• Drug Product Process Development: Develop robust processes with high fill accuracy, and high sterility assurance, and success rate

• Scale-up: Scale-up of drug product processes to technical plant scale, transfer to GMP operations (clinical or commercial), provide technical support to operations

• Drug Product Manufacturing: Manufacture drug product following current Good Manufacturing practices (cGMP) – internally or through CMO’s – for Phase 1, 2 and 3 clinical trials

• Novel Delivery: Develop novel delivery systems (e.g. nanoparticles) for patient-friendly drug product of next generation biologics.

• Device Integration: In close collaboration with Medical Device group, integrate the formulation with primary container and with the administration devices to enable fast progression of projects.

• Innovation and External Collaborations: Identify and engage in technology development through internal work and/or external collaborations in the above areas

• Business Development support: Support BD as well as Mergers/Acquisitions as needed to support Sanofi’s R&D pipeline strategy

• Develop strategies to efficiently progress the biologics pipeline.

• Involved in developing / contributing to / executing strategies for the organization as a member of the Global CMC Leadership Team

• May be asked to lead high level teams across the company to achieve strategic goals

• Collaborate with academia, other companies in licensing / M&A activities

• Responsible for activities in Framingham USA; Vitry, France and Frankfurt, Germany

Basic Qualifications:

• Ph.D. in Chemical, Biochemical Engineering, or a related discipline with a minimum of 20 years of relevant industry experience in biologics CMC

• A minimum of 5 years of experience managing a large team of scientists and/or engineers

• Demonstrated experience bringing biopharmaceutical products to global markets

• Experience managing formulation development and drug product development

• Knowledgeable in all aspects Biologics development with special emphasis on CMC aspects – process, formulation, analytics, manufacture, technology transfer.

• Knowledgeable in quality requirements and regulations as well as recent trends that govern biological molecule CMC development and BLA submissions

• Knowledgeable with specific needs of the various therapeutic areas – for example Oncology, Rare Diseases, Immunology, Inflammation, Neuroscience etc., - and how to translate them to CMC plans.

• Growing list of peer-reviewed publications/presentations in the Biologics CMC field, including patents and conference presentations

• Demonstrated ability learn new topics quickly and contribute to developing a strategy or solving problems.

• Ability to participate in and present to executive leadership on project and portfolio plans

• Strategic thinking and enterprise leadership

• Ability to influence colleagues in other functions to achieve common goals

Preferred Qualifications:

• Ph.D. in Chemical, Biochemical Engineering, or a related discipline specializing in biologics

• Global leadership experience leading / influencing multi-cultural teams

• Working with a heightened sense of urgency to deliver our rich portfolio

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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