Process Development Radiochemist - Hamilton, Canada - Fusion Pharmaceuticals

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 immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

Currently, Fusion relies on CDMOs for the scale up and production of its compounds, including its radiolabelled drug products, backed-up by a strong R&D team for the early development of manufacturing and analytical process. In addition, Fusion has recently completed the construction of a 27,000 sqf GMP production facility that aims to support clinical material production, in support of Fusion's clinical activities.

Position

Fusion Pharmaceuticals is opening the role of "Process Development Radiochemist" to support the design of manufacturing and analytical processes as well as the technology transfer, in-house and with CDMO partners. This role will report to the Process development manager.

This position requires collaborative skills, multi-tasking ability, and the desire to strive in a fast-paced environment. The successful candidate will bring a strong background in radiolabelling and radiometal chemistry, as well as knowledge in analytical method development.

Responsibilities

• Execute the laboratory work and tasks related to the development of manufacturing and analytical processes for targeted alpha therapies.
• Analyze generated data and report outcomes to the project's teams.
• Support the Process Development team with technical activities related to processes development, validation, or qualification.
• Generate supporting documentation for new designed processes such as standard operating procedures (SOP), work instructions, validation documentation (e.g.: process and equipment validation, validation report).
• Participate in validation and qualification activities for new clinical manufacturing processes and analytical methods.
• Support the CMC group during investigation (non-conformance, deviation, out-of-specification)

Qualifications

• Min. MS with 5+ years of experience in product development and manufacturing; Advanced degree in organic or analytical chemistry, radiochemistry, radiopharmaceutical sciences, Pharmaceutical Science, Chemical Engineering, or related scientific discipline is a must.
• Experience in radiopharmaceuticals manufacturing and analytical methods development and validation is a must.
• Experience in process scale-up using automated synthesis unit is an asset.
• Knowledge in radiation safety principles/dangerous goods and regulations (e.g. CNSC, NRC).
• Strong interpersonal skills are required, and the successful candidate will work in a cross-functional team and will be expected to take a leadership position in key manufacturing projects.
• Excellent written and verbal communication skills with an ability to adapt to various partners and geography.
• Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced start up environment.
• Available to travel to various locations (primarily in North America) is a must.

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.