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The Associate Director position is part of the Upstream team in the Recombinant Drug Substance function within global Manufacturing Sciences, Analytics, & Technology (MSAT) and is based at the Mammalian Platform hub in Framingham, MA. The MSAT mission is to enable the reliable supply of medicines by providing expert technical and scientific support for their licensure, ongoing commercial manufacturing, and life-cycle management activities.
Join our global network that contributes to the launch of 20 new products in the next 5 years across various modalities and to an expansive portfolio, enabling us to reach and serve more patients and communities. Collaborate with a team of talented and passionate international experts, scientists, and project leaders who are dedicated to inventing, designing, and implementing cutting-edge industrial chemical and biological processes, analytical methods, and process modelling, all in support of Sanofi's best-in-class ambition.
The Recombinant Drug Substance function within global MSAT is the owner of Life Cycle Management (LCM) of DS processes. Implementation of second-generation processes is one of the top performance enablers for Sanofi's biologics manufacturing network and integral to LCM. We deliver innovative, robust, and cost-effective next generation processes. In recent years we have successfully established second-generation manufacturing mammalian processes with a continuous process platform. The function is responsible for tech transfer, process validation, dossier preparation, & PAI support to enable launch of new and LCM products. We are pursuing future innovations such as digital labs, factory of the future, and advanced-analytics-based process understanding and control.
The successful candidate will manage a team of scientists and engineers responsible for tech transfer support of legacy and next generation cell culture processes across a network of manufacturing facilities, process validation support, and commercial manufacturing support of process-related investigations and process improvements for commercial products. We are looking for a candidate with excellent scientific, communication, and people management skills. This individual will work in a fast-paced, team environment, collaborating with colleagues across functions in the organization to solve a wide range of complex problems, and leading the Upstream Manufacturing Sciences team to meet department and site deliverables.
Main Responsibilities:
Lead a team of scientists and engineers comprising the Upstream manufacturing sciences team and oversee their professional development
Manage a team leading multi-product technical support in upstream commercial process operations at the Framingham site.
Manage a team supporting NPI, technology transfer, facility fit, FMEA, process validation and process control strategy definition for introduction of new products and processes at manufacturing scale.
Provide technical leadership in process monitoring, CPV, root cause investigation, change assessment, product impact assessment, and continuous improvement.
Coach a technical team utilizing a solid understanding of scientific principles and professional practices to solve a range of complex deviations and technical issues in manufacturing in creative and practical ways.
Represent MSAT management in interactions with Engineering, Manufacturing, Quality, and other site stakeholders. Provide input and advice on process-related investigations and LCM process improvements.
Author and support regulatory filings and health authority inspections. Coach a team responsible for preparing reports and other internal documentation for regulatory purposes.
Collaborate with MSAT and CMC Development colleagues across the global biologics manufacturing network on NPI and tech transfers, process adaptations for facility / equipment fit, and process design and control strategy definition, with a broad range of SMEs and leaders in upstream, downstream, analytical, pilot plant, biostatistics, and modeling functions.
About You
Experience and Education:
Degree in life sciences, engineering, or other relevant degree
Minimum years of experience: BS with 13 years, or MS with 10 years, or PhD with 8 years
Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
Minimum 3 years of experience managing a technical team and developing people
Preferred qualifications:
Excellent scientific and engineering background, technical writing, and presentation skills
Experience managing, coaching, and developing scientific and engineering staff
Highly motivated individual with the ability to influence cross-functional and cross-site teams and to effectively communicate with project leaders and department and site management
Experience with perfusion and other continuous-based cell culture processes, their development and/or industrial implementation
Hands-on experience with mammalian cell culture operations at laboratory, pilot, or manufacturing scale
Experience with successfully leading technology transfers, PPQ, and process control strategy establishment
Experience with design and start-up of new facilities
Experience with advanced process monitoring, data analysis, and CPV
Experience with change assessment, product impact assessment, quality event management, and APR
Experience with authoring regulatory filings and supporting PAI and other health authority inspections.
Self-motivated with excellent attention to detail and having a proven ability to work in a highly collaborative environment and communicate transversally.
Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset.
Demonstrated ability to become a cell culture SME in a relevant field for mammalian-expressed proteins, e.g. advanced data monitoring and analytics, process automation and digitization, bioreactor design and scale up
Knowledgeable in other cell culture systems and modalities, such as microbial culture or vaccine manufacturing
Why Choose Us?
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.
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.
