Fusion Pharmaceuticals
  • Hamilton, ON, CAN
  • Full Time

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2024.

Fusion Pharmaceutical is opening a role for a Senior Director, Manufacturing, the ideal candidate will have experience working with biologics and small molecules. This individual will be responsible for leading and coordinating the required internal and external resources to develop and executing the near and long-term strategy to maximize manufacturing outcomes, and proactively plan for changing conditions. In addition, this position will identify, evaluating, and proposing manufacturing organizations and strategy.

This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. The successful candidate will bring a strong background of GMP manufacturing and management of external vendors. We are a clinical stage company with strategic partnerships, so this is a highly visible and impactful role in our growing organization. At this time we are open to candidates in Hamilton, Ontario or Boston, MA.

Responsibilities:

  • Set manufacturing strategy for Fusion's internal pipeline of products
  • Overall responsibility for all process development and manufacturing activities from preclinical clinical development through commercialization.
  • Identification, selection and management of Contract Development & Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture of Drug Substance and Drug Product (DP) in support of ongoing clinical programs and subsequent commercial supply in compliance with cGMP, ICH and FDA regulations.
  • Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans.
  • Manage and mentor internal staff
  • Build an internal group responsible for small molecule process development and optimization
  • Understanding and influencing the development of analytical methods and specifications needed to support process research and development of small molecules.
  • Understanding and influencing the CMC regulatory environment to provide a phase appropriate strategy supporting process
  • Interaction with regulatory agencies, as needed, to act as a technical subject matter expert regarding small molecule developments.

Qualifications:

  • PhD or MS with 10+ years of experience in product development and manufacturing; Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred.
  • cGMP Manufacturing experience in biologics and small is required; experience with antibody drug conjugates is preferred.
  • A proved track record leveraging and managing US and international CRO/CDMOs for the manufacture of cGMP APIs and DP to meet aggressive timelines.
  • Strong interpersonal skills are required, and the successful candidate will work in a cross-functional team and will be expected to influence the direction of the late-stage clinical programs.
  • Excellent written and verbal communication skills with an ability to convey CMC strategies and results to a varied audience.
  • Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced start up environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Fusion Pharmaceuticals
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share This Page
.
Fusion Logo Technology About Careers Media Pipeline