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 highly motivated Associate Scientist to join the Bioanalysis group within Biomarkers & Clinical Bioanalysis (BCB), a global department within the Translational Medicine and Early Development unit of Sanofi.
The individual in this position should have hands-on experience in the development, validation and implementation of biological 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.
Biomarkers and Clinical Bioanalysis 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 BCB highly visible and members are key contributors to program teams. The individual in this position will have the opportunity to support multiple projects and to collaborate transversally with colleagues across the globe, each contributing expertise in a complimentary aspect of drug discovery and development.
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:
Manage multiple project commitments under the confines of challenging timelines.
Develop, validate, and implement complex bioanalytical assays to support PK, immunogenicity, and biomarker testing in nonclinical and clinical studies.
Assume responsibility for critical reagent sourcing and maintain adequate supply and inventory.
Serve as the bioanalytical lead for assigned projects and Principal Investigator for regulated studies following internal best practices and regulatory guidance's.
Author standard operating procedures, study plans and reports and analytical work plans.
Take a leadership role in ensuring compliance of laboratory equipment and serving as SME for operation and software.
Manage multiple project commitments under the confines of challenging timelines.
Work with outsourcing operational group and CROs to transfer and manage external testing efforts.
About You
Earned PhD in the field of immunology, biochemistry, biology, or other life-science field, OR Master's degree with 3+ years of relevant experience, OR Bachelor's degree with 6+ years of relevant industry experience required
A diverse skillset in bioanalytical assay techniques such as ligand binding, multiplexed biomarker analysis, enzyme activity assays needed
Outstanding written and oral communication skills along with the ability to work collaboratively in a team setting essential
Demonstrated knowledge and skills in solving scientific problems, ability to troubleshoot required
Familiarity with industry's best practices in bioanalytical assay development and regulatory expectations (FDA and EMA) for validation of PK, immunogenicity and biomarker assays is ideal
Experience working in a regulated environment (GLP, GCLP) in support of nonclinical and clinical development projects would be helpful
Experience with multiple platforms and applications (MSD, Ella, Gyros, Simoa, ELISPOT, etc.) preferred
Familiar with instrument application software and basic statistical software such as EXCEL, SoftMax Pro, GraphPad Prism, etc. ideal
Experience working with a laboratory information system, such as Watson LIMS, to manage sample tracking and data analysis, as well as with electronic laboratory notebooks such as Benchling is preferred
Why Choose Us?
Position supports career growth within the scientific track.
The individual in this position will have the opportunity to contribute to the development of novel biotherapeutics including enzyme replacements, nanobodies, multi-specific antibodies and gene therapies to treat a variety of disease indications.
The BCB department provides a fast-paced, dynamic and collaborative environment where management, scientists and research associates work as a team to develop complex and cutting edge biological assays.
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.
