Cmc Coordinator - Hamilton, Canada - Fusion Pharmaceuticals US Inc

Fusion Pharmaceuticals US Inc
Fusion Pharmaceuticals US Inc
Verified Company
Hamilton, Canada

3 weeks ago

Sophia Lee

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Sophia Lee

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Description

Fusion Pharmaceuticals (


NASDAQ:
FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors.


Fusion's clinical portfolio includes:

FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial.

In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immune-oncology agents.

To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with Niowave, and BWXT Medical.


As the
CMC Coordinator reporting into the Manager, Radiopharmaceutical CMC you will be involved in the development, implementation and monitoring of CMC driven programs.

In addition, you will assist in establishing processes for both internal and external manufacturing sites including the tracking and storage of data at these sites.

In this function, the CMC Coordinator will work closely with a cross functional team of production and process development specialists, and also Quality Assurance and Regulatory Affairs

Fusion has recently opened a state-of-the-art radiopharmaceutical manufacturing facility. The good manufacturing practice (GMP) compliant facility is now operational supplying patients for clinical trials.

As part of Fusions radiopharmaceutical manufacturing department, the
CMC coordinator will help support activities that feed into each individual program to support submissions/filings.

This position is ideally based in Hamilton, ON. Some travel may be required to CDMO sites.


Responsibilities:


  • Establish processes to track data across internal manufacturing site and external CDMO's.
  • Source CMC relevant information for studies for Fusion stakeholders (such as clinical, nonclinical departments)
  • Plans, directs, and coordinates CMC studies to support program/projects.
  • Authoring and maintenance of CMC modules 2 and 3, as well as IMPDs.
  • Assesses program status and implements appropriate actions.
  • Develop procedures and SOPs for manufacturing sites.
  • Work cross functionally with the Quality assurance team into processes investigations and implementation of preventive actions with our manufacturing partners.
  • Preparation of original protocols, reports or other forms of summary descriptions of relevant scientific and technical information in line with instructions and regulatory authority requirements.
  • Organize data to support the group's function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).

Qualifications

  • A minimum BSc in chemistry or health sciences (life sci) is required.
  • 2+ years of experience in the pharmaceutical industry, prior radiopharmaceuticals experience is ideal.
  • Experience in assisting with the relevant CMC sections of INDs, NDAs, BLAs, CTAs, IMPDs preferred.
  • Knowledge in processes development for pharmaceuticals (manufacturing and quality controls) is a must.
  • Good understanding of the radiation safety regulations (US NRC/Canada CNSC) and guidelines is preferred.
  • Experience in working in a manufacturing environment internal or external manufacturing)
  • Organized with proven ability to work independently.
  • Excel working in a collaborative environment as a member of a multidisciplinary team.
Willingness to take on new tasks and responsibilities as required and support other team members in ensuring department activities (e.g. Support for CMC activities review of clinical production, deviation, or non-conformance)

  • Must have the ability to organize and manage tasks, schedules, and information efficiently.
  • Must be flexible and able to handle changing priorities.
  • Must be able to manage multiple tasks simultaneously.


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

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