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Senior Director, Analytical Development

Company: Finch Therapeutics
Location: Somerville
Posted on: January 9, 2022

Job Description:

Somerville, Ma - Technical Development - Full-time Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch's lead candidate, CP101, is in late-stage clinical development for recurrent -C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn's disease, respectively. Responsibilities / Duties

  • Develop and oversee strategy for phase-appropriate deployment of analytical methods and testing for early and late phase drug programs
  • Work closely with senior management team to initiate new projects and drive implementation to meet objectives.
  • Design, build, and lead the Finch Analytical Development function.
  • Collaborate with Translational Medicine, Research, Manufacturing, and Quality teams to support tech-transfer activities.
  • Contribute significantly to the development of phase-appropriate method qualification and work with QC to develop validation protocols and test method SOPs for routine performance of these assays.
  • Effectively communicate results of departmental work to other parts of the organization both verbally and in writing.
  • Participate in and contribute to developing strategy and budget planning.
  • Perform work in accordance with relevant regulatory agency guidance (e.g., FDA, ICH, EMA, etc.) as well as Company policies and procedures. Qualifications
    • Advanced degree (e.g. Ph.D.) in chemistry or pharmaceutical sciences with focus on analytical aspects of drug development.
    • A minimum of 10 years of relevant late stage and commercial industry experience is required.
    • Broad technical expertise in analytical development for complex biologics, especially in molecular biology (e.g. qPCR, etc.) and cytometric techniques such as flow cytometry.
    • Direct experience working with live biotherapeutics, or live vaccines is highly desired.
    • Proven experience in developing and implementing analytical methods used to support product development, characterization, and release.
    • Working knowledge of CMC regulatory requirements for biological pharmaceutical products in various stages of development as well as practical application of principles of QbD.
    • Outstanding at problem-solving and applying creative innovative solutions to multifaceted problems and issues and a passion for working in a fast-paced and evolving organization.
    • Experience leading a high performing team of scientists and associates. More About Finch Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we'll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
      • Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
      • We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our office is stocked with free snacks and beverages and we sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team. *Only facility-dependent employees are working on-site until further notice. Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.

Keywords: Finch Therapeutics, Somerville , Senior Director, Analytical Development, Executive , Somerville, Massachusetts

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