Associate Director, Genomic Medicine Purification Process Development

Sanofi•Waltham, MA

12d•$147,000 - $212,333•Onsite

About The Position

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced gene therapy products, including recombinant AAV vectors and non-viral LNP particles. Sanofi is looking for an experienced purification process development professional with experience in GMP manufacturing and technology transfer (TT) to join the GMU Purification Process Development (PPD) Group located in Waltham, MA in the role of Associate Director. The GMU PPD group operates with the mission to develop robust, scalable, and innovative viral vector purification processes for Sanofi’s genomic medicine pipeline. The successful candidate will work with a group of scientists and engineers responsible for the development of viral vector purification processes, technology transfer to manufacturing sites, overseeing process scaling up, defining scale down models, and associated regulatory filing activities. We are looking for a candidate with excellent scientific, communication, and project management skills. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Requirements

PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant industry experience or a Master’s degree with a minimum of 10 years of industry experience or a Bachelor’s degree with a minimum of 12 years of relevant industry experience.
Background specializing in Technology Transfers and new product introductions to GMP facilities
Strong technical background in AAV purification process
Experience with AAV cGMP Manufacturing, especially in purification operations
Experience of engaging external CDMOs within the biopharmaceutical industry

Responsibilities

Have extensive knowledge of GMP manufacturing and technology transfer to manufacturing sites
Make strong technical and strategic contributions to cross functional project teams
Subject matter expert for executing technology transfers to external CDMOs
Act as the first/primary point of contact for familiarization and staying current with CDMO technical capabilities and limitations, including but not limited to equipment, instrumentation, facility, process fit, and engineering design.
Execute and improve the established standard ways of working and harmonize TT practices across programs and CDMOs. Examples of standard work include creating templates for TT risk and gap assessments, process descriptions, etc.
Closely collaborate and stay current with internal process development to ensure external transfer is aligned with internal development efforts, and vice versa. Advise where studies or changes are required to address gaps
Actively engaged with internal pilot scale up labs to identify operation gaps and streamline ways of working and actively participate in the execution of internal pilot batches.
Actively participate internal and external project teams and subteams to enable the above responsibilities
Serve as a primary representative for Person-in-Plant (PiP) responsibilities to oversee CDMO activities during GMP runs
Requires the ability to travel more than 20% of the time

Benefits

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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