Director Bioanalytics Characterization

Job Title: Director Bioanalytics Characterization

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. Join our Bioanalytics Mammalian team as Director of Bioanalytics Characterization and you’ll be able to play a key role in supporting CMC biologics development at Sanofi.

The Director of the Characterization team will lead a group of approximately 20 scientists, whose main mission is to support the extended characterization testing of biologics (e.g. enzymes, antibodies, fusion proteins) from early-stage development (Phase I/II) through licensure. The Characterization team is responsible for performing the activities to support the elucidation of structure, reference standard characterization, comparability, host cell protein identification, as well as supporting CQA assessments through degradation pathway and in-depth variant characterization studies. This position resides within the Mammalian Bioanalytics group, which is part of the Global Biologics CMC Development organization at Sanofi, Framingham, MA.

We are looking for a skilled, highly motivated individual capable of taking on a leadership role in protein therapeutic development. The individual must have proven ability to manage a high performing scientific team and oversee characterization studies in line with regulatory expectations for biologics for all phases of 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:

• Oversee all characterization activities required to support structure-function assessments of protein biologics including primary sequence verification, charge and size variant characterization, as well as the identification of impurities in accordance with regulatory expectations and internal Sanofi guidance documents. 

• Ensure compliance with environmental health and safety requirements. This includes, but is not limited to, employee training, documentation, equipment qualification, and data integrity.

• Provide strategic input and direction regarding the evaluation/implementation of new analytical technologies for the characterization of biologics and relevant impurities with an emphasis on state-of-the-art methods and techniques.

• Provide strong scientific mentorship to direct reports who have both managerial and CMC analytical project leadership roles. Provide characterization support for process and product development, cell line development and developability activities. Contribute to the authoring and review of CMC regulatory filings and responses to information requests. 

• Maintain a high level of employee engagement through training, career development initiatives, job rotations, mentoring, and alternating assignments.

• Provide strategic input and direction regarding capital equipment investment decisions for new equipment to ensure adequate capability and capacity is available to support state of the art characterization testing of mAbs, multispecific antibodies, fusion proteins, and enzymes

• Design and adapt characterization studies based on CQA knowledge, proposed process control strategies, as well as emerging industry trends

• Ensure compliance with data integrity requirements and documentation practices consistent with expectations for studies supporting regulatory filings

• Take a leading role in supporting Sanofi’s company-wide strategic analytical initiatives, including the authoring of guidance documents.

• Represent Sanofi through participation in industry forums, presenting at conferences and the preparation of high quality publications

About You

• Ph.D. in Biochemistry, Analytical Chemistry, or related discipline with at least 10 years of relevant experience working in the biotechnology/pharmaceutical industry, or a Master’s or Bachelor’s Degree and at least 14 years of relevant experience.

• Broad expertise in the characterization of proteins including biophysical techniques to assess higher order structure and mass spectrometry to support PTM analysis and primary sequence verification.

• Experience leading characterization teams and mentoring staff.

• Demonstrated success in managing development programs and in planning and implementing characterization and CMC strategies for the development of large molecule biologics.

• Experience writing regulatory submissions and responding to information requests

• Good understanding of regulatory expectations regarding the use of QbD, CQAs, Analytical Target Profile, to support rapid development of new molecules and establish suitable control strategies

• Excellent oral and written communication skills, collaborative, and self-motivated.

• Recognized by industry peers as evidenced by publications, invitations to present at external conferences, or through participation in scientific organizing committees

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 safe 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.