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Senior Director/Director, Manufacturing Sciences & Technologies

Fusion Pharmaceuticals

Fusion Pharmaceuticals

Sales & Business Development
Massachusetts, USA · United States · Boston, MA, USA · Remote
Posted on Thursday, March 14, 2024

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion links 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. The Company recently received IND clearance for FPI-2068, the first novel TAT under the collaboration, which targets EGFR-cMET. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with Niowave, and BWXT Medical.

The company opened its own manufacturing facility in 2023, located in Hamilton Canada, that is currently supporting the clinical manufacturing of FPI-2265 a phase 2 asset, under clinical trials in North America.

Fusion is looking to expand the CMC team, by adding a Senior Director/Director of Manufacturing Sciences and Technologies (MS&T), to support the fast-growing clinical demand, and prepare the company radiopharmaceuticals manufacturing processes and technologies to meet late phase and commercial requirements.

The individual will partner with a highly cross-functional team to support the production of radioligand therapies and diagnostic agents, in compliance with the regulatory and quality requirements. The newly created function will lead the technical oversight of the manufacturing network (in-house and outsourced production from a processes and technologies standpoint), manage the development life cycle, and deploy the automation technology to support the scale-up activities. To be successful, the individual will require proven experience in radiopharmaceuticals manufacturing processes development, and leadership to drive effective communication along the cross-functional groups.

This role will be reporting to the Vice-President of Radiopharmaceuticals Manufacturing and based at the company’s Canadian Headquarters in Hamilton, Ontario (Canada) or remotely in North America (preferably EST time zone).

Responsibilities

  • Develop and lead the MS&T function to oversee the radiopharmaceuticals manufacturing processes and technologies within Fusion manufacturing network, in-house and outsourced.
  • Provide technical leadership for the design and optimization of manufacturing processes. Work closely with cross functional groups (including CMC, process R&D, isotopes solutions, quality, regulatory, etc.) to collect user requirements.
  • Communicate effectively with the cross-functional team to identify the needs for the qualification, validation, and regulatory filing of the manufacturing processes.
  • Identify and deploy manufacturing technologies (such as hotcells and isolators, synthesizers, dispensing technologies) to support processes scale-up.
  • Build and maintain processes bill-of-materials, according to the processes’ lifecycles.
  • Maintain the relationship with key vendors, to source the ad-hoc equipment and support needed for the deployment and maintenance of manufacturing technologies.
  • Build and maintain systems to monitor processes and technologies performance and metrics, to optimize maintenance needs, support quality events such as investigations, Out-of-specification, change controls.
  • Own the ad-hoc projects for implementing processes, at-scale, according to the programs’ timelines.

Requirements

  • Minimum Master’s degree in sciences, engineering, or related field.
  • A minimum of 10 yrs. experience in radiopharmaceuticals manufacturing processes and technologies, including radiosynthesizer, dispensing systems (vials, syringes) required.
  • Proven experience in radiopharmaceuticals manufacturing processes start-up, technology transfer, and validation.
  • Excellent teamwork and interpersonal skills and ability to build strong relationships with internal and external stakeholders.
  • Ability to manage critical deadlines in a fast paced and dynamic environment, as required by the business.
  • Experienced in critical regulations (occupational health & safety, radiation safety, devices, and quality standards (cGMP, Eudralex, ICH).
  • Strong analytical and problem-solving skills with proven ability to induce changes and improvements within a cross functional group.

LI#-Remote

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.