Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) 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-2284, a radioconjugate targeting six-transmembrane epithelial antigen of the prostate-2 (STEAP2), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
The Role: Fusion is looking for a Manager, Technology Transfer. The successful candidate will be responsible for leading technology transfer activities amongst Fusion’s external manufacturing sites. This role will report to the Head of Process Development. The successful candidate must have experience with the manufacture of investigational products, have strong leadership and collaborative skills, and have the ability to adapt in a fast-paced environment. This position can be based out of either our Hamilton, Ontario or Boston, Massachusetts locations.
Responsibilities:
- Plan, initiate and execute technology transfer projects to external manufacturing (CDMO) sites. The primary focus will be the transfer of manufacturing processes and analytical methods.
- Provide technical oversight for the implementation of new processes and technologies to different manufacturing sites.
- Assist with troubleshooting at the CDMO to ensure timely deliverables and key milestones are met.
- Coordinate with the internal process development team to implement new or updated manufacturing processes and analytical methods to external manufacturing sites.
- Lead recurring team meetings internally and with external manufacturing partners by developing structured agendas, facilitating discussions, and distributing minutes.
- Communicate and coordinate technology transfer activities cross-functionally.
- Support the selection committee from the initial search to the contract awarding phase by establishing key deliverables for the CDMO.
- Travel to external manufacturing sites to provide on-site support, as necessary.
Qualifications:
- Min. MS with 6+ years experience in product development and manufacturing (early phase to commercial); Advanced degree in Organic or Analytical Chemistry, Radiochemistry, Radiopharmaceutical Sciences, Pharmaceutical Science, Chemical Engineering, or related scientific discipline is preferred.
- Experience with external manufacturing oversight, including process and analytical method development and validation, is desirable.
- Background in radiolabelling and radiometal chelation chemistry, and experience with radiopharmaceutical manufacturing processes and analytical methods is an asset.
- Strong project management and organizational skills.
- Excellent communicative and interpersonal skills that lead to successful collaborative working relationships with external partners and key colleagues across the organization.
- Strong leadership skills, and demonstrated ability to exercise sound judgment on key technical issues.
- Experience working with CDMOs in Asia is a plus for this position
- Available to travel to various locations, within the restrictions imposed by countries and the company travel policy. Travel approximately 15%-25%.
Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes, if contacted for an interview, please advise Human Resources if you require accommodation.
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.