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Sanofi Group Senior Director Gene Therapy Bioanalytics in Framingham, Massachusetts

Reporting to the Head of Bioanalytics, the Head of Gene Therapy Bioanalytics will lead a group of approximately 45 scientists, involved in 1) the development, qualification and transfer of methods to internal and external commercial QC units, 2) characterization and comparability of gene and cell therapy molecules and 3) analytical support for formulation, upstream and downstream development to support gene therapies and and non viral vectors. The Gene Therapy Bioanalytics group will also be responsible for QC testing support for Preclinical, Phase 1, and Phase 2 cell and gene therapy molecules. The Head of Gene Therapy Bioanalytics will represent Bioanalytics on the Genomic Medicine Unit (GMU) CMC leadership team.

Key Responsibilities:

  • Oversee the department’s GMP sample support, including IPC, release and stability testing, performed in house as well as at CROs. Provide oversight and guidance for GMP investigations including deviations root cause analyses, CAPA, and out-of-specifications.

  • Oversee the Bioprocess analytics group to ensure timely turnaround to support vector and cell line, process and formulation development.

  • Oversees the Characterization group to characterization and further understand structure functional relationships of lentivirus, AAV and cell therapies.

  • Oversee the method development, qualification/validation and transfer of analytical methods to and from the GM analytics teams by collaborating internally with research and MSAT teams and externally with CROs/CMOs.

  • Set the strategy for evaluating and implementing new technologies within the GM Bioanalytics group, with an emphasis on state-of-the-art separation sciences, cell based and molecular technologies and automation. Collaborate with Bioanalytics assay cell line selection and automation skill centers to achieve this goal.

  • Provide strong scientific mentorship to direct reports who have both managerial and CMC analytical project leadership roles that support process development, specification setting, and CMC regulatory filings and responses.

  • Collaborates within the Genomic Medicine Unit and Bioanalytics teams to streamline our WOW to ensure quality but improve efficiency and cost of goods.

  • Design and adapt analytical paradigms based on the CQAs, process control strategies and emerging industry trends.

  • Take a leading role in setting Sanofi company-wide strategic analytical initiatives for ATMPs, including authoring guidance documents.

  • Manages and oversee the long- and short-term planning and supervision of projects, by prioritizing and determining group goals to achieve company objectives.

  • Develops, hires and maintains key personnel in the group.

  • Provides technical and regulatory guidance to ensure that the methods and products are developed in accordance with company and industry standards.

  • Collaborates on patent applications and manuscripts for publication.

  • Represents the company as a contact person for external contracts and collaborations.

Basic Qualifications:

  • PhD in a cell or molecular biology or relevant discipline with a minimum of 12 years of relevant industry experience, or Master’s or Bachelor’s degree with a minimum of 16 years of relevant industry experience

  • Minimum of 7 years of managerial experience.

  • Expertise in gene therapy (viral and non viral) analytics e.g. for AAV, LNPs, mRNA therapies, as well as a strong understanding of cell and molecular biology.

  • An understanding of regulatory requirements and trends related to analytics and product development for gene and cell therapies.

  • Experience leading teams in the development, qualification/validation and transfer of analytical methods and working in a GMP environment.

  • Experience in planning and implementing analytical and CMC strategy for the development of AAV, LNPs and mRNA based therapies.

  • Experience acting as an analytical team leader

  • Experience writing regulatory submissions, audits and meetings.

  • Understanding of how QbD, CQAs and process control strategies are related.

  • Excellent communication skills.

Preferred Qualifications:

  • Experience developing and implementing analytical platforms using QbD.

  • Proven experience streamlining WoW to ensure quality but improve efficiency and reduce costs.

  • Experience acting as a CMC project leader.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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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