Director, Production Scheduling

at  Fusion Pharmaceuticals US Inc

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.
Director, Production Scheduling reporting into the VP, Supply Chain and Logistics will be responsible for supporting Director, External Radiopharmaceutical manufacturing operations. This is a remote position.

Responsibilities

• Collaborating with Contract Development Manufacturing Organizations (CDMOs), the internal manufacturing site team, Clinical Operations team to strategically plan manufacturing activities, update master manufacturing schedule, and manage clinical site slot requests. Providing high-level oversight of calibration sample availability and communicating executive-level manufacturing forecasts to ensure timely clinical drug supply delivery.
• Overseeing Sales & Operations Planning (S&OP) to align production, clinical demand, and supply chain activities with organizational objectives.
• Managing radioactive source ordering to ensure timely availability for clinical and manufacturing needs while maintaining compliance with safety and regulatory requirements.
• Working on cross-functional planning efforts for new material introductions within the master manufacturing schedule and delivering executive updates on key activities and project progress.
• Working on clinical readiness initiatives for new programs with CDMOs and internal manufacturing partners, ensuring alignment of internal stakeholders’ timelines and expectations with those of external clients.
• Overseeing or preparing and maintaining manufacturing demand projections based on clinical demand.
• Developing, implementing, and continuously improving Standard Operating Procedures (SOPs) and Work Instructions for departmental and cross-departmental activities.
• Mentoring new team members and supporting department training initiatives.
• Providing strategic leadership to ensure departmental goals aligning with organizational objectives and driving continuous improvement initiatives.
• Performing other duties as required by the business.

Qualifications

• A Bachelor’s or Master’s degree in Chemistry, Engineering, Health Sciences, or a related field.
• 10+ years of experience in manufacturing, supply chain management, or project management, with a significant portion of experience in leadership roles within the pharmaceutical or radiopharmaceutical industry.
• Demonstrated experience in leading cross-functional teams and managing complex manufacturing schedules.
• Exceptional organizational and strategic planning skills with a track record of successfully managing large-scale projects and meeting critical deadlines.
• Outstanding communication and leadership abilities, with the capability to effectively influence and negotiate with stakeholders at all levels.
• Proficiency in project management tools and software.
• Experience with CDMOs and familiarity with external manufacturing processes is highly desirable.
• Comprehensive knowledge of GMP regulations, clinical drug supply processes, and quality assurance practices.
• Detail-oriented with a proactive approach to problem-solving.
• Ability to work effectively in a fast-paced, multidisciplinary team environment.
• Proficient in MS Office Suite, including Excel, Word, and PowerPoint.

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 orientation, gender identity, national origin, disability, or status as a protected veteran.

• Collaborating with Contract Development Manufacturing Organizations (CDMOs), the internal manufacturing site team, Clinical Operations team to strategically plan manufacturing activities, update master manufacturing schedule, and manage clinical site slot requests. Providing high-level oversight of calibration sample availability and communicating executive-level manufacturing forecasts to ensure timely clinical drug supply delivery.
• Overseeing Sales & Operations Planning (S&OP) to align production, clinical demand, and supply chain activities with organizational objectives.
• Managing radioactive source ordering to ensure timely availability for clinical and manufacturing needs while maintaining compliance with safety and regulatory requirements.
• Working on cross-functional planning efforts for new material introductions within the master manufacturing schedule and delivering executive updates on key activities and project progress.
• Working on clinical readiness initiatives for new programs with CDMOs and internal manufacturing partners, ensuring alignment of internal stakeholders’ timelines and expectations with those of external clients.
• Overseeing or preparing and maintaining manufacturing demand projections based on clinical demand.
• Developing, implementing, and continuously improving Standard Operating Procedures (SOPs) and Work Instructions for departmental and cross-departmental activities.
• Mentoring new team members and supporting department training initiatives.
• Providing strategic leadership to ensure departmental goals aligning with organizational objectives and driving continuous improvement initiatives.
• Performing other duties as required by the business