Senior Director, Analytical Development
Company: Finch Therapeutics
Posted on: January 9, 2022
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
- Work closely with senior management team to initiate new
projects and drive implementation to meet objectives.
- Design, build, and lead the Finch Analytical Development
- Collaborate with Translational Medicine, Research,
Manufacturing, and Quality teams to support tech-transfer
- 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
- 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
- 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
- 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
Keywords: Finch Therapeutics, Somerville , Senior Director, Analytical Development, Executive , Somerville, Massachusetts
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