Location
Framingham, MA | United States
Job description
Position Overview/Department Description
We seek a highly motivated Associate Director, IP Quality Control to join the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The successful candidate will be responsible for leading an In-Process testing group, which supports the manufacturer of Sanofi’s clinical cell therapy products. The manager will have the overall responsibility to oversee the testing of rapid flow cytometry & alternative cell counting techniques, supporting qualification/validation of methods and bridging activities, where needed. The ideal candidate will have excellent communication and organization skills, and a proven ability to work with a high level of integrity, accuracy, and attention to detail. This group will be located in Framingham, MA and will have regular daytime hours, although flexibility to cover unforeseen challenges outside of these hours is required.
Key Responsibilities:
Leads an efficient team of three shifts (2xAM and 1xPM shifts) capable of consistently delivering in process testing (in process control and in process monitoring) to support the manufacturing of clinical cell therapy products in a GMP environment.
Provide and supervise analytical support for manufacturing operations, including qualification of in-process methods and assist in technology transfers both internally and externally in support of GMP manufacturing.
Ensures cGMP compliance through direct oversight and education of team members.
Oversees the responsibility of scheduling testing personnel in coordination with other BioA leadership.
Responsible for hiring, onboarding, training, and coaching and development of staff.
Manages direct reports’ projects to achieve department and corporate goals, including managing timelines and leading group meetings.
Work closely with process and analytical development teams, as well as manufacturing to continuously improve the analytical tools, efficiency and ways of working used to support in process testing and manufacturing.
Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality investigations, deviations, CAPAs, change controls, and risk assessments.
Manages direct reports’ projects to achieve department and corporate goals, including managing timelines and leading group meetings.
Creates, revises, and reviews-controlled documents including Standard Operating Procedures (SOPs), qualification protocols and technical reports.
Serves as a technical SME for the team, troubleshoots problems independently
Oversee internal and external assay transfers consistent with established procedures, and ensure compliance to procedures.
Basic Qualifications:
PhD in a relevant discipline and a minimum 8 years of relevant experience or Master’s degree in a relevant discipline with a minimum of 12 years of relevant experience or a Bachelor’s degree a relevant discipline with a minimum of 14 years of relevant experience
A minimum of 2+ years direct supervisory experience
Expertise in cGMP and Quality Metric Systems
Experience in flow cytometry testing and/or development for a gene or cell therapy project
Relevant demonstrated experience in troubleshooting flow cytometry-based analytical methods
Proven ability to design and implement efficient ways of working and develop logistics and methods to handle high throughput and rapid turnaround testing.
Excellent computer skills including Word, Excel, Outlook, equipment interfaces and electronic quality systems.
Excellent organizational and communication skills
Preferred Qualifications:
Experience with business management and efficiency tools, for example Six Sigma, Lean tools, 5S
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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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.
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