Principal Scientist, Lab Head Quality Processes

Job Title: Principal Scientist, Lab Head Quality Processes

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are seeking a Principal Scientist, Lab Head to join the US-based Laboratory Sciences group within the Translational Medicine Unit of Sanofi. The individual in this position will oversee a team of individuals responsible for developing and maintaining a robust quality system to support regulated bioanalysis for nonclinical and clinical studies in a GLP/GCLP laboratory.  The position will work closely with scientists and technical staff to support generation, review and reporting of high-quality data in compliance with internal quality systems and regulatory guidelines (GLP / GCLP). Additionally, this position will be responsible for leading projects related to the implementation of new analytical instrumentation and software and the maintenance of existing equipment.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Ensure audit preparedness and work closely with site quality operations to maintain compliance with regulatory guidance documents. 

• Serve as system administrator for laboratory software and facilitate the validation and implementation of quality systems in the laboratory. 

• Program, maintain and optimize data storage and archival functions for the department.

• Manage the review process for analytical data, study plans and reports.

• Providing QC process training, assign QC tasks and schedule audits.

• Author and review standard operating procedures to define quality processes.

• Independently author equipment validation documentation (e.g., design specification, user requirements, GxP impact, test cases).

• Take a leadership role in ensuring regulatory and safety compliance in the laboratory; promote operational excellence by leading process improvement efforts. 

• Work with global teams to develop and operationalize quality processes to support new and ongoing programs.

• Manage teams responsible for equipment management, maintenance and calibration.

• Oversee data reporting and submission.

• Manage multiple project commitments under the confines of challenging timelines.

About You

Requirements & Qualifications

Basic Qualifications:

• The candidate must hold a bachelor’s degree in the field of immunology, biochemistry, biology, or other life-science field with 10+ years of experience working in a GxP regulated setting, master’s degree with 7+ years of experience, or PhD with 5+ years of experience.

• Experience managing teams.

• Experience with quality events (deviations, CAPA, etc.).

• Demonstrated experience in GxP lab operations such as preparation of SOPs, reporting data, writing method validation reports, tracking project deliverables and timelines, and/or maintaining instrument use logs.

• Experience performing lab work in a GxP setting.

• Outstanding written and oral communication skills with high attention to detail.

Preferred Qualifications:

• A diverse skillset in equipment and computerized equipment validations and experience with controlled documentation.

• Ability to work collaboratively in a team setting.  

• Experience