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 in supporting GLP nonclinical studies and GCLP clinical studies.
• Familiar with instrument application software and basic statistical software such as EXCEL, SoftMax Pro, MSD, Analyst, FSC express, Watson LIMS, etc.
• Familiar with industry’s best practices in bioanalytical assay development and regulatory expectations (FDA and EMA) for validation of PK, immunogenicity and biomarker assays

What makes this position unique?

Laboratory Sciences is a global group that plays a critical role in the development of new drugs, contributing bioanalytical strategy and support from nonclinical development to clinical proof of concept. The growing need for translational studies makes Laboratory Sciences highly visible and members are key contributors to program teams. The individual in this position will have the opportunity to represent the US site in global project teams and contribute to harmonization of processes between sites.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.