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-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), 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.

Fusion Pharmaceutical is opening a role for a Sr Director/Director of Manufacturing. Reporting to the Vice President of Manufacturing, this individual will be responsible for leading the development and production of all targeting moieties (precursors) for the Fusion portfolio. This will include managing the internal and external resources required to support the short and long-term goals of the organization. The ideal candidate will have experience working with biologics and small molecules.

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.

Responsibilities:

•    Set manufacturing strategy for Fusion's 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 Precursors 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 

•    Understanding and influencing the development of analytical methods and specifications needed to support process research and development of targeting moieties .

•    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 precursor development. 

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 small molecules/peptides is required; experience with biologics and antibody drug conjugates is preferred. 

•    A proven 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.