Scientist

Job Title: Scientist

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 Scientist to join the ligand binding bioanalysis group within Laboratory Sciences, a global department within the Translational Medicine Unit of Sanofi. The individual in this position should have hands-on experience in the development, validation and implementation of ligand binding assays for the analysis of biomarkers, pharmacokinetics and immunogenicity. This position will work in a team setting to develop complex assays, implement testing strategies, execute projects to meet controlled timelines, and prepare reports suitable for regulatory submission to support clinical development.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were 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

• Independently develop, validate, and implement complex bioanalytical assays to support PK, immunogenicity, and biomarker testing in nonclinical and clinical studies

• Serve as responsible scientist for regulated studies; provide scientific oversight and data interpretation and ensure data meets compliance requirements according to internal best practices and regulatory guidance.

• Author standard operating procedures, study plans and reports, and abstracts; present scientific data to fellow colleagues

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

• Manage multiple project commitments under the confines of challenging timelines

• Work with global teams to develop and operationalize testing strategies to support new and ongoing clinical programs

• Work with outsourcing operational group and CROs to transfer and manage external testing efforts. Act as subject expert to review and troubleshoot CRO development and validation studies.

About You

Basic Qualifications:

• Earned Ph.D. in the field of immunology, biochemistry, biology, or other life-science field with post-graduate experience, OR Masters degree in a related field with 3+ years of experience, OR Bachelors degree in a related field with 6+ years of experience

• Pharmaceutical industry experience preferred

• A diverse skillset in bioanalytical assay techniques such as ligand binding (ELISA, MSD, Gyros, ProteinSimple, Qaunterix, etc.), and multiplexed biomarker analysis, and enzyme activity assays

• Demonstrated experience with method development and validation, with evidence of independently developed and validated ligand binding assays.

• Outstanding written and oral communication skills along with the ability to work collaboratively in a team setting

• Demonstrated knowledge and skills in solving scientific problems, ability to troubleshoot

• Experience directing the work of junior staff members in assay development efforts

Preferred Qualifications:

• Familiar with industrys best practices in bioanalytical assay development and regulatory expectations (FDA and EMA) for validation of PK, immunogenicity and biomarker assays

• Experience working in a regulated environment (GLP, GCLP) in support of nonclinical and clinical development projects.

• Experience working with a laboratory information system, such as Watson LIMS, to manage sample tracking and data analysis.

• Experience using an electronic laboratory notebook, such as Benchling.

• Experience developing neutralizing antibody assays.

• Knowledge of biological sample collection techniques and their suitability for different types of analysis

• Familiar with instrument application software and basic statistical software such as EXCEL, SoftMax Pro, JMP, GraphPad Prism, etc.

• Experience validating software and equipment in a regulated laboratory setting.

• Experience supporting regulatory filings.

• Experience with clinical trial operations.

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 its 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.

#GD-SG
#LI-GZ
#LI-Onsite
#vhd

Better is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .