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Sanofi Group Director, Bioassays and Molecular Biology in Framingham, Massachusetts

Overview

This position resides within the Genomic Medicine Unit (GMU) which is part of Sanofi’s CMC Development organization. The GMU 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 gene therapy candidates. The group supports the development and cGMP-compliant release and stability testing of clinical supplies.

We are looking for a skilled and highly motivated leader with broad expertise in gene therapy and cell biology method development to join the GMU Analytical Development group in Framingham, MA (this lab will be moving to Waltham, MA in Q3 2022). The selected candidate will manage and develop a team of scientists and research associates who are tasked with performing potency and residuals method development and validation to enable rapid progression of various gene therapy candidates into the clinic.

Key responsibilities:

  • Establish and oversee a high performing team capable of supporting analytical development activities for gene therapy candidates with an emphasis on potency and residuals methods.

  • Evaluate and implement new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art cell-based techniques (potency, residuals, cytokine expression, etc)

  • Maintain a cGMP-compliant laboratory environment and ensure departmental SOPs, internal Sanofi standards and applicable regulations are consistently followed

  • Write/review method protocols, assay qualification and validation plans/reports and ensure that the documents adhere to GxP requirements and ICH guidelines

  • Oversee in-process, release and stability testing as per the GxP and ICH guidelines

  • Write/review analytical sections of IND/IMPD filings to enable use of cell and gene therapy candidates in the clinic

  • Provide technical oversight and manage workload and staff assignments. Set priorities and objectives for staff to ensure timely completion of deliverables as per the project timelines

  • Develop team members by providing challenging assignments, performance assessments, and coaching

  • Provide guidance and mentorship to help junior staff with their career growth

  • Interface with third party contract laboratories as needed to manage project workload

  • Ensure compliance to regulatory and corporate safety standards

  • Represent analytical development in setting Sanofi company-wide strategic analytical initiatives, including authoring guidance documents

Basic Qualifications:

  • Ph.D. in Biochemistry, Cell Biology/Molecular Biology, or a related discipline with a minimum of 10 years of relevant industry work experience or a Master’s or Bachelor’s degree with a minimum of 14 years of relevant industry experience

  • Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and regulatory filings, preferably for cell and gene therapy products

  • Sound understanding of regulatory requirements for early-stage development of biologics including compendial requirements as well as requirements associated with the assessment of critical quality attributes, control strategies, stability, and comparability as outlined in ICH Guidelines and FDA guidance documents

  • Experience acting as an analytical team leader/representative on CMC teams

  • Excellent communication skills

  • Experience managing people in project-based or functional teams

  • Strong background in cell-based methods (e.g. potency, residuals, cytokine expression, etc), excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches

  • Working experience in a GMP environment and ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered an advantage

Preferred Qualifications:

  • Experience with qPCR, ddPCR, ELISA, Flow Cytometry, and/or related techniques will be desirable

  • General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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