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Associate Director, Bioassay and Molecular Analytical Develo

Company: Sanofi
Location: Framingham
Posted on: February 23, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the--Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our--colleagues will explain how these tools will be used throughout the recruitment process and will be on hand to answer any questions you might have. Associate Director, Bioassay and Molecular Analytical Development, Genomic Medicine Unit From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Do you have what it takes for a successful career with Sanofi? We seek an energetic and highly motivated Associate Director to join the newly formed Bioassay and Molecular Analytical Development (BAM) group within the Genomic Medicine Unit (GMU) and Bioanalytics groups in Framingham, MA. The successful candidate will lead the design and implementation of cell and ligand based and molecular assays to support gene and cell therapy programs in all phases of clinical development. The role will manage a team of scientists and associates who develop, qualify and implement analytical methods for drug product release and characterization within a GMP environment. The incumbent will also be responsible for writing patent applications and/or external publications as an outcome of the innovation and technology advancements. Key Responsibilities:

  • Lead a group of scientists and associates responsible for bioassay and molecular method development, phase appropriate qualification/validation for cell and gene therapy programs.
  • Evaluate and implement new technologies within the BAM group, with a particular emphasis on cell and binding based assays.
  • Collaborate across the larger Bioanalytics group with the assay cell line engineering team and automation teams to develop state of the art, phase appropriate bioassays for AAV, lentiviral and cell therapy products.
  • 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
  • Write/review analytical sections of IND/IMPD filings to enable use of gene and cell 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.
  • Represents GMU Bioanalytics in setting Sanofi company-wide strategic analytical initiatives, including authoring guidance documents.
  • Participate in CMC teams as an Analytical Team Lead responsible for defining the analytical testing plan including the definition of drug product CQAs and development of appropriate analytical assays to measure these attributes in cell and gene therapy programs Basic Qualifications:
    • PhD in a life sciences discipline with a minimum of 8 years of relevant industry experience, or a Master's or Bachelor's degree with a minimum of 12 years of relevant industry experience.
    • Proven expertise/experience in developing and qualifying/validating analytical methods to support product development and regulatory filings, preferably for gene and/or cell therapy products.
    • Strong background in cell and molecular based methods (e.g. bioassay, ligand binding, flow cell cytometry and molecular assays), excellent method troubleshooting skills, as well as appropriate experience in developing potency analysis approaches e.g. 4 parameter fit, parallelism etc. with respect to regulatory guidance.
    • Sound understanding of regulatory requirements for early stage development of gene and/or cell therapy 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
    • Minimum 5+ years of experience managing people in project-based or functional teams Preferred Qualifications:
      • Experience working in a matrixed environment Global experience
      • Experience in a GMP environment that translates into the ability to adhere to all appropriate GMP standards (e.g. invalid result investigations, deviations, and CAPAs) will be considered an advantage.
      • General understanding of statistical principles supporting method performance and robustness assessments as well as Design of Experiment approaches used for method development/optimization
      • Track record in writing patents and external publications 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. #GD-SA #LI-SA 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. Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

Keywords: Sanofi, Framingham , Associate Director, Bioassay and Molecular Analytical Develo, Executive , Framingham, Massachusetts

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