Note: The job is a remote job and is open to candidates in USA. Nuclidium is a radiopharmaceutical company developing precision theranostic solutions based on copper isotopes Cu-61 and Cu-67. The Project Manager, Technical Operations will plan and lead complex pharmaceutical development, manufacturing, technology-transfer, CMC, and related technical projects while coordinating internal teams and external partners. The role is responsible for maintaining project plans, managing risks and dependencies, facilitating communication, and driving timely execution and manufacturing readiness.
Responsibilities
- Plan and coordinate technology transfers involving CDMOs, contract manufacturers, testing laboratories, engineering partners and other service providers
- Establish joint plans, milestones, governance routines, action logs and escalation pathways with external partners
- Track readiness of facilities, equipment, materials, methods, documentation and personnel required for transfer and manufacturing execution
- Coordinate internal review and resolution of issues affecting partner delivery, quality, timing or scope
- Lead complex, cross-functional Technical Operations projects from initiation through completion, including projects involving external partners
- Develop integrated plans covering scope, deliverables, milestones, dependencies, resources, decision points and ownership
- Maintain schedules and action trackers, follow up on commitments, and drive workstreams toward agreed outcomes
- Coordinate activities across process development, CMC, manufacturing, engineering, Quality, Regulatory, Supply Chain and Clinical Operations, as applicable
- Manage multiple priorities while maintaining focus on critical details, project outcomes and manufacturing readiness
- Facilitate project meetings, documenting decisions, actions, ownership and deadlines
- Translate technical information into clear priorities and concise updates for technical and nontechnical stakeholders
- Maintain current risk, issue, dependency and decision logs; assess potential effects on scope, timing, quality, cost and downstream activities
- Drive structured issue resolution and escalate significant risks or decision needs promptly with clear options and recommendations
- Prepare project dashboards and leadership reports, maintain controlled project documentation, and capture lessons learned
- Work in accordance with applicable GxP requirements, company procedures and regulatory commitments, partnering with Quality and subject-matter experts as required
Skills
- Bachelor's degree in life sciences, pharmacy, chemistry, engineering, biotechnology or another relevant scientific or technical discipline
- Demonstrated success managing complex pharmaceutical, biotech, manufacturing, technology-transfer or technical-operations projects involving multiple functions and external partners
- A working understanding of pharmaceutical manufacturing, technology transfer, process development, CMC, Quality or related technical-operations activities
- Strong cross-functional communication, including the ability to translate technical information into clear priorities for technical and nontechnical stakeholders and to work effectively across organizational and cultural boundaries
- Sound judgment in identifying and managing risks, issues and dependencies, facilitating resolution and escalating appropriately
- A proactive, structured approach to execution, with strong organization, follow-through and attention to critical details while managing multiple priorities
- Proficiency with standard project-management, collaboration and reporting tools and professional fluency in English
- Radiopharmaceuticals, nuclear medicine, radioisotopes, sterile injectable products or another complex pharmaceutical manufacturing environment
- Direct management of technology transfers to CDMOs or contract manufacturing organizations, including manufacturing readiness, process validation, analytical activities or related CMC workstreams
- Work in a global pharmaceutical organization, particularly across U.S. and European teams or with international external-manufacturing partners
- An advanced degree or formal project-management qualification is advantageous but not required
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