Associate Director Cell Therapy AD-QC-Impurities GMU Bioanalytics

Position Overview/Department Description

This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Cellular Therapy Analytical Development and Quality Control group (CT AD/QC) has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust identity, strength, and impurity methods to support release and characterization testing of different cell therapy candidates. In addition, the group supports cGMP-compliant release and stability testing of clinical supplies performing both the product-specific as well as compendial methods.

We are looking for a skilled and highly motivated scientist with broad expertise in immunophenotyping and cell sorting to join the GMU CT AD/QC group.  This group will be moving locations from Framingham, MA to Waltham, MA by Q1 2023.

Key Responsibilities:

• Lead multi-functional development team to establish and evolve current cell therapy analytical methods and strategies

• Defines broad technical objectives and champions pioneering analytical capabilities to enhance product characterization, structure, and function

• Understanding of Cellular Therapy regulatory guidance’s, and ability to translate requirements to develop clinically relevant process control strategies and product attribute profiles

• Troubleshoot existing protocols to increase method performance, throughput and ergonomic control, evaluating novel technology platforms to advance and supersede existing capabilities and limitations

• Responsible for leading projects with complex interactions, internally and/or externally.

• Oversee the design, planning, and execution of complex methods and transversal projects, and performs deep data dives

• Work closely with process and analytical development teams, as well as manufacturing to identify analytical deficiencies and propose relevant and meaningful solutions for enhanced process understanding and control

• Support or lead manufacturing investigations and contribute to root cause analysis and correction action planning

• Manage groups documentation practices reviewing study plans, reports, and operating procedures, as well as author and/or contribute to technical reports

• Actively investigate new technologies to complement improved product characterization and process control, with a focus on automation and high throughput needs

• Oversee internal and external assay transfers consistent with established procedures, and ensure compliance to procedures

• Contribute to routine assay support as needed, following established procedures and group documentation practices

• Manage individual development plans, and mentor staff for technical understanding and career growth

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 12 years of relevant experience

• Demonstrated experience in developing residual and impurity analytical methods

• Experience developing and implementing novel methods to improve process and product understanding with proven troubleshooting skills

• Innovative, critical, and creative thinker

• Excellent organizational and communication skills

• Experience in mentoring and/or managing direct reports

Preferred Qualifications:

• Experience as a cell-based team leader for cell therapy project(s)

• Experience with Flow Cytometry and panel design

• Experience with multiple platforms used for highly sensitive residual testing

• Experience viral and adventitious testing strategies

• Experience in method transfers and gap analysis risk assessment processes

• Experience using QbD principles and tools e.g., DOE to develop analytical methods.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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.