Senior Manager, Production Planning
Fusion Pharmaceuticals
This job is no longer accepting applications
See open jobs at Fusion Pharmaceuticals.See open jobs similar to "Senior Manager, Production Planning" Ontario Bioscience Innovation Organization .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.
As the Manager, Production Planning reporting into the Director, External Radiopharmaceutical Manufacturing Operations you will be responsible for supporting external manufacturing projects. This individual will facilitate scheduling meetings, follow up on project tasks, and track progress against key milestones. This position is located onsite in Hamilton, Ontario, Canada.
Responsibilities
• Collaborating with Contract Manufacturing Organizations (CMOs), the internal manufacturing site, and Clinical Operations to plan manufacturing, oversee the master manufacturing schedule, approve clinical site slot requests, ensure calibration sample availability, and communicate weekly manufacturing forecasts to both internal and external stakeholders to ensure clinical drug supply is delivered on time.
• Working with internal stakeholders to plan new material introduction activities within the master manufacturing schedule and providing regular updates on ongoing activities and project statuses.
• Managing clinical readiness for new programs with CMOs and internal manufacturing partners while aligning internal stakeholders' timelines and expectations with those of external clients.
• Preparing and maintaining manufacturing demand projections based on clinical demand.
• Ensuring all batch records are updated and securely stored in Box upon completion of manufacturing.
• Assisting in outlining and drafting Standard Operating Procedures (SOPs) and Work Instructions for departmental activities.
• Mentoring new team members and supporting department training initiatives.
• Performing other duties as required by the business.
Qualifications
• A BSc/MSc in chemistry, engineering, or health sciences.
• 5+ years of experience in manufacturing, supply chain management, or project management within the pharmaceutical or radiopharmaceutical industry.
• Strong organizational skills with a proven ability to manage multiple tasks and meet deadlines.
• Excellent communication and interpersonal skills to work collaboratively with internal and external stakeholders.
• Proficiency in project management tools and software.
• Experience with CMOs and familiarity with external manufacturing processes is highly desirable.
• Knowledge of GMP regulations and clinical drug supply processes is a strong asset.
• 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.
• Willingness to take on new tasks and responsibilities as required.
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.
This job is no longer accepting applications
See open jobs at Fusion Pharmaceuticals.See open jobs similar to "Senior Manager, Production Planning" Ontario Bioscience Innovation Organization .