CMC Project Leader

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; 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 CMC Project Leader. Reporting to the Vice President of Manufacturing, this individual will be responsible for leading CMC efforts for our lead asset, FPI-2265 and representing CMC on the Global Program team.

This high visibility position requires excellent communication skills, multi-tasking ability, and desire to strive in a fast-paced environment. The successful candidate will bring a strong background in CMC and Project leadership.

This position is based out of our Boston, MA office and will follow a hybrid work schedule.

Responsibilities:

• Has overall accountabilìty for defining and delivering the pharmaceutical development strategy that delivers effective development, approval, commercialization and LCM of new medicines.
• The key CMC accountabilities include
  • The overall development and technical strategy
  • The regulatory strategy and documentation for marketing authorizations (incl IND/IMPD)
  • For in-market products, the role holder is accountable for the development and delivery of the Manufacturability Strategy & Plan.
  • Clinical supply chain strategy and plan for Phase 3 (transferred generally at start of Phase 3)
• Accountable to the Global Program Team (GPT) for maintaining and delivering all aspects of the pharmaceutical development plan including control of the scope, timing, resources, cost, quality and risk.
• An active member of the GPT, contributing to the development of overall project strategies. Is expected to have credibility and influence within the team in which the role holder is a member.
• Accountable for the technical development strategy for APl, DP & Analytical aligned with project strategy and priority.
• The role involves a diverse range of problems/opportunities requiring complex judgements and solutions based on highly developed levels of conceptual thought and strategic vision and analysis.
• May represent CMC on the evaluation of business development opportunities .
• Has the responsibility to ensure that project strategies are reviewed

Skills and Qualifications:

• 10+ years experience in product development and manufacturing; Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred. PMP certification a plus
• Demonstrated strong leadership with enterprise mindset, learning agility, networking and negotiation skills and collaborative approach supportive of delivery of business objectives.
• Demonstrated strong interpersonal and communication skills with ability to set clear direction and objectives for the team and to influence at a senior level in the organization including Governance groups
• Capable of managing the responsibilities for a diverse range of activities and projects acting as the key sponsor for projects and programs supporting their project portfolio.
• Excellent negotiation and influencing skills in order to influence and contribute to the cross-functional project/product strategies and deliverables
• Possess strength and independence of viewpoint and be willing to challenge others in senior roles in other parts of Global Operations and the rest of the business when appropriate
• Ability to develop & implement end-to-end Pharmaceutical strategy across all CMC areas (APl, DP, etc.) aligned with the overall GPT strategy and clinical/commercial supply
• Significant experience of leading multi-disciplinary teams with an ability to ensure correct structure and team composition for efficient delivery and transition across the value stream
• Strong coaching and motivational leadership skills that support the development of and delivery through the Pharmaceutical Team

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.