Scientist, Analytical Development

Job Title: Scientist, Analytical Development

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.

Sanofi is seeking a highly motivated Scientist to join the Analytical Development and QC group within Mammalian Bioanalytics, located in Framingham, MA. The Analytical Development group has the overall responsibility to establish phase-appropriate control strategies and to develop, qualify, and validate robust analytical methods to support release and characterization testing of different antibody and protein therapeutics candidates. In addition, the AD group is responsible for cGMP-compliant release and stability testing of clinical supplies and performs both compendial as well as product-specific methods. The goal of all these activities is to enable rapid progression of multiple therapeutic candidates into the clinic.

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

• Participate in and/or lead the development, qualification, and transfer of analytical methods in support of drug substance and drug product release and stability testing.

• Independently plan and perform experiments across multiple development projects simultaneously and document the work in an electronic lab notebook. Integrate, compile, analyze, and interpret data.

• Perform cGMP sample testing, following method protocols (SOPs), and compile and review data packets.

• Ensure timely completion and delivery of all analytical results and documentation (technical reports, SOPs, ELN, LIMS, etc.) to support product development during clinical phases.

• Deliver high quality documents and effectively communicate progress and experimental results to supervisor and team members.

• Assist junior staff in their experimental planning and coordination.

About You

Basic Qualifications

• Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with 0-2 years of relevant experience working in the biotechnology/ pharmaceutical industry or MS with 3-5 years of relevant working experience.

• Separation sciences will be the key focus area of the candidate’s work. Expertise and proven ability to apply his/her knowledge to establish analytical methods for monoclonal antibodies and other complex proteins is expected. Therefore, a strong background in CE-SDS, including familiarity with instrumentation from different vendors, excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches are required. Proficiency with the use of tools such as 32Karat and Empower is a must.

• Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.

• Proven capability of evaluating/developing new technologies in an independent manner and be able to propose/design implementation strategies if deemed appropriate.

• Excellent written and verbal communication skills.

• Must be able to work collaboratively in a fast-paced, team-oriented environment.

Preferred Qualifications

• Method development/validation experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs).

• Hands-on experience with CE-SDS and other protein separation techniques or physicochemical methods (e.g., cIEF, HPLC, UV-Vis) in a pharmaceutical or biotechnology setting.

• Proficient in Microsoft Word, Excel, PowerPoint, ELN, and application of basic statistics.

• Must be organized, efficient, and able to work according to timelines.

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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