Sanofi Group Lead, Drug Product Manufacturing Sciences and Technologies, Waltham, MA in Waltham, Massachusetts
The individual will be part of a strategic and dynamic Manufacturing Sciences and Technology group that is highly focused on transitioning late-stage programs through commercialization and supporting life cycle management of commercial products. We are looking for a highly energetic individual who has deep technical knowledge in biologics drug product manufacturing process to lead process validation, technology transfer and commercial manufacturing process support activities.
The successful candidate will:
Be experienced with both liquid fill and lyophilization processes. Lead drug product process characterization, tech transfer and manufacturing support for designated products. Participate on multiple CMC teams as DP lead. Lead drug product process validation at internal or external manufacturing sites: define process control strategies, lead risk assessments, draft/review/approve PPQ documentation Author relevant filing sections and responses to agency questions Continue to support routine manufacturing, monitor process performance and develop life cycle management strategy for improved robustness and yield
In-depth technical experience in a drug product process development, tech transfer, process validation and manufacturing support. Experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical operations, commercial and regulatory functions. Demonstrated leadership and capability for strategic analysis and issue resolution, organizational and project management skills. Excellent communication, negotiation, problem solving and decision making skills and a strong ability to influence or manage without direct authority.
Ph.D. in Chemical Engineering/Chemistry or related field with 5+ years’ experience or MS with 8+ years of experience in relevant industry.
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.
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