Senior Specialist, External Manufacturing
About The Position
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radio conjugates (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 radio conjugate 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.
Requirements
- Minimum BSc in chemistry, engineering, or health sciences.
- 3+ 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.
- 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.
- Willingness to take on new tasks and responsibilities as required.
Nice To Haves
- MSc. In chemistry, engineering, or health sciences
- Experience with CDMOs and familiarity with external manufacturing processes
- Ability to communicate effectively in Mandarin
Responsibilities
- Collaborating with Contract Development Manufacturing Organizations (CDMOs), the internal manufacturing site, and Clinical Supply Chain team to ensure 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.
- Support cross-functional planning and execution of tech transfer, scale-up, process characterization, and validation (PPQ/PV).
- Ensure equipment/facility readiness, comparability, and robust control strategies.
- Partner with QA to ensure GMP compliance, inspection readiness, data integrity, and robust deviation/CAPA and change control.
- Support internal and external audits and regulatory inspections.
- Assisting in outlining and drafting Standard Operating Procedures (SOPs) and Work Instructions for departmental activities.
- Support with financial management of invoice approval for payment.
- Performing other duties as required by the business.
Benefits
- Annual base salary for this position ranges from 99,552.80 to 130,663.05.
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days.
- Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
