Sanofi Group Head of Continuous Manufacturing Process Development Group in Framingham, Massachusetts
Head of Continuous Manufacturing Process Development Group
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
Job Responsibilities/Department Description:
Biopharmaceutics Development at Sanofi develops and implements manufacturing processes for biologics starting with an early and strong interface with Biologics Research. It encompasses cell line development, GMP cell banking, upstream- downstream and formulation development, assay development, manufacturing drug substance and drug product for toxicological and clinical studies, release and stability testing (QC). Biopharmaceutics development drives identification, development & introduction of new state-of-the-art technologies, and provides launch capable processes and analytical methods at the interface to biologics manufacturing.
Seeking a highly motivated and innovative individual to lead a process development group focused on continuous manufacturing, within the Biopharmaceutics Development department. This position reports to the site head of the Biopharmaceutics Development group in Framingham. The main focus of the group is to develop and implement cutting edge continuous manufacturing solutions for a variety of biological candidates. Technology development is the primary focus of this group, with some support provided to projects. The role involves significant cross functional collaboration with other functions, including Research and Development, Manufacturing, Regulatory and Quality, to ensure platforms have a strong regulatory and technical foundation as well as being robust and well-controlled. The role will have global impact through collaborations across various groups within the organization.
Bachelor degree in Chemical or Biochemical Engineering, Chemistry or Life Sciences with 8 years biopharmaceutical industrial experience
Ph.D. or Master’s degree preferred
Experience with continuous manufacturing platforms
Demonstrated technical proficiency, scientific creativity, and innovation individually and in collaboration with others.
Demonstrated understanding of biopharmaceutical process development, scale-up and validation
Experience with clinical and commercial drug substance manufacturing
Mammalian cell culture, purification and assay development and analytical characterization experience
Process validation, including process characterization studies, and process performance qualification
Understands the importance/relevance of various health authority requirements
Excellent problem solver and ability to think creatively
Ability to evaluate new technologies
Excellent communication skills and ability to influence across the organization
Ability to set ambitious targets and successfully drive results
Highly flexible, works well in a team environment, and has the skills necessary to organize, communicate and influence, with an unquestionable level of integrity.
Demonstrated proficiency in oral and written communication and an innovative problem solver
Job: Laboratory/Process/Device Development
Primary Location: United States-Massachusetts-Framingham
Job Posting: Jan 12, 2017, 3:50:38 PM
Job Type: Regular
Employee Status: Regular