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 plans and leads complex projects across pharmaceutical development, manufacturing, technology transfer, CMC and related technical activities while coordinating internal functions and external partners.
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
- - An advanced degree or formal project-management qualification is advantageous but not required
- - 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
Benefits
- Full-time employment
- Remote work arrangement
Company Overview