Fusion Pharmaceuticals
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 is opening a role for a
CMC Project Leader . Reporting to the Vice President of Manufacturing, the candidate will lead CMC efforts for our lead asset, FPI-2265, and represent CMC on the Global Program team.
The position is based in our Boston, MA office and will follow a hybrid work schedule.
Responsibilities
Define and deliver the pharmaceutical development strategy that delivers effective development, approval, commercialization and LCM of new medicines.
Accountability for the overall development and technical strategy.
Accountability for the regulatory strategy and documentation for marketing authorizations (incl IND/IMPD).
For in‑market products, develop and deliver the Manufacturability Strategy & Plan.
Develop clinical supply chain strategy and plan for Phase 3 (transferred generally at start of Phase 3).
Maintain and deliver all aspects of the pharmaceutical development plan, including control of scope, timing, resources, cost, quality and risk.
Act as an active member of the GPT, contributing to the development of overall project strategies, and hold credibility and influence within the team.
Accountable for the technical development strategy for APL, DP & Analytical aligned with project strategy and priority.
Represent CMC in the evaluation of business development opportunities.
Review project strategies to ensure alignment and quality.
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 a collaborative approach supporting delivery of business objectives.
Strong interpersonal and communication skills, with ability to set clear direction and objectives for the team and influence at a senior level, including governance groups.
Capable of managing the responsibilities for a diverse range of activities and projects as the key sponsor for projects and programs supporting their portfolio.
Excellent negotiation and influencing skills to contribute to cross‑functional project/product strategies and deliverables.
Strong independence of viewpoint, willing to challenge others in senior roles throughout Global Operations and the rest of the business when appropriate.
Ability to develop and implement end‑to‑end pharmaceutical strategy across all CMC areas (APL, DP, etc.) aligned with overall GPT strategy and clinical/commercial supply.
Significant experience leading multi‑disciplinary teams, ensuring correct structure and composition for efficient delivery and transition across the value stream.
Strong coaching and motivational leadership skills supporting the development 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.
The annual base pay for this position ranges from $162,682.40 to $244,023.60. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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Fusion is opening a role for a
CMC Project Leader . Reporting to the Vice President of Manufacturing, the candidate will lead CMC efforts for our lead asset, FPI-2265, and represent CMC on the Global Program team.
The position is based in our Boston, MA office and will follow a hybrid work schedule.
Responsibilities
Define and deliver the pharmaceutical development strategy that delivers effective development, approval, commercialization and LCM of new medicines.
Accountability for the overall development and technical strategy.
Accountability for the regulatory strategy and documentation for marketing authorizations (incl IND/IMPD).
For in‑market products, develop and deliver the Manufacturability Strategy & Plan.
Develop clinical supply chain strategy and plan for Phase 3 (transferred generally at start of Phase 3).
Maintain and deliver all aspects of the pharmaceutical development plan, including control of scope, timing, resources, cost, quality and risk.
Act as an active member of the GPT, contributing to the development of overall project strategies, and hold credibility and influence within the team.
Accountable for the technical development strategy for APL, DP & Analytical aligned with project strategy and priority.
Represent CMC in the evaluation of business development opportunities.
Review project strategies to ensure alignment and quality.
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 a collaborative approach supporting delivery of business objectives.
Strong interpersonal and communication skills, with ability to set clear direction and objectives for the team and influence at a senior level, including governance groups.
Capable of managing the responsibilities for a diverse range of activities and projects as the key sponsor for projects and programs supporting their portfolio.
Excellent negotiation and influencing skills to contribute to cross‑functional project/product strategies and deliverables.
Strong independence of viewpoint, willing to challenge others in senior roles throughout Global Operations and the rest of the business when appropriate.
Ability to develop and implement end‑to‑end pharmaceutical strategy across all CMC areas (APL, DP, etc.) aligned with overall GPT strategy and clinical/commercial supply.
Significant experience leading multi‑disciplinary teams, ensuring correct structure and composition for efficient delivery and transition across the value stream.
Strong coaching and motivational leadership skills supporting the development 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.
The annual base pay for this position ranges from $162,682.40 to $244,023.60. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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