Job Description

Position Overview:

This position resides within the Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization. The GMU Flow Cytometry group has the overall responsibility to establish phase appropriate control strategies and to develop, qualify, and validate robust flow cytometry methods to support release and characterization testing of different cell and gene 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 Flow Cytometry group.  This group will be moving locations from Framingham, MA to Waltham, MA by June 2022.

Key Responsibilities:

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

Define broad technical objectives and champion pioneering analytical capabilities to enhance product characterization, structure and function.

Understand gene therapy regulatory guidance and 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 both internally and 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 the group's 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 and mentor staff for technical understanding and career growth.

Basic Qualifications:

PhD in Life Sciences or related discipline with a minimum 8 years of relevant industry experience or Master’s or Bachelor's degree with a minimum of 12 years of relevant industry experience.

Demonstrated experience in developing gene therapy specific analytical methods.

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

Experience developing automated and high throughput methods with particular emphasis on immunophenotyping and cell sorting assays for gene or cell therapies.

Innovative, critical, and creative thinker.

Excellent organizational and communication skills.

Experience in managing direct reports and/or technical teams.

Preferred Qualifications:

Experience as a flow cytometry team leader for a gene or cell therapy project.

Experience in method transfers and gap analysis risk assessment processes.

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