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CMC Project Leader

CMC Project Leader

Fusion PharmaceuticalsProvidence, RI, United States
11 hours ago
Job type
  • Full-time
Job description

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.

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    Project Leader • Providence, RI, United States

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