Technical Project Manager

Role Summary

The Technical Project Manager will lead and manage moderately to complex technology transfer and clinical supply projects within sterile injectable manufacturing. This role requires a strong foundation in science or engineering, project management, hands‑on experience in aseptic processing, and the ability to design, execute, and interpret technical and validation studies. The successful candidate will serve as a technical leader with strong project‑management capabilities, collaborating cross‑functionally to ensure timely and compliant delivery of manufacturing solutions.

• Lead cross‑functional teams to execute technology transfer projects, including scale‑up, process optimization, and validation for sterile injectable drug products.
• Manage clinical supply projects, ensuring alignment with regulatory timelines and quality standards.
• Design and execute technical studies (e.g., formulation evaluations, equipment assessments, process characterization).
• Author and review validation documentation including protocols, reports, and risk assessments in accordance with cGMP and regulatory expectations.
• Serve as a technical SME in sterile injectable manufacturing, providing guidance during audits and inspections.
• Collaborate with internal and external stakeholders including R&D, Quality, Regulatory, and Contract Manufacturing Organizations (CMOs).
• Utilize established project‑management methodologies to develop and maintain accurate timelines, budgets, and resource allocations using appropriate tools and systems.
• Lead comprehensive project planning, execution, monitoring, and closure efforts in alignment with recognized frameworks such as Waterfall, Agile, or Lean.
• Facilitate stakeholder engagement and alignment, proactively manage risks, ensure on‑time project delivery, and drive effective resource coordination throughout the full project lifecycle.

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate’s degree with at least 8 years of experience or high school diploma (or equivalent) with at least 10 years of relevant experience.
• Demonstrated experience in commercial/customer‑facing roles across the business.
• Experience in sterile injectable manufacturing or aseptic processing.
• Hands‑on project‑management experience preferably in a regulated manufacturing or pharmaceutical environment with demonstrated experience in project‑management and cross‑functional leadership.
• Knowledge of the workings of pharmaceutical manufacturing and associated processes.
• Experience working in a Pharmaceutical Good Manufacturing Practices (cGMP) environment.
• Familiarity with Pharmaceutical Sciences infrastructure.
• Proactive and creative entrepreneurial attitude with evidence of ability to execute key projects.
• Strong analytical and problem‑solving skills.
• Excellent communication, technical writing, and stakeholder engagement skills.

• Experience with technology transfer, clinical trial material production, and validation lifecycle management.
• Project Management Professional (PMP) certification or equivalent.
• Proficiency with project‑management platforms and tools (e.g., MS Project, Planner).
• Ability to work collaboratively in a cross‑functional team environment.
• Ability to adapt to changes in business strategies and operational imperatives.
• Ability to mentor and guide junior colleagues.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

• Physical requirements include sitting, standing, bending, or walking.
• Moderate lifting (up to 25 lbs) and extended periods of standing or walking may be required.
• Ability to write general correspondence, technical reports, perform mathematical calculations, data analysis, and problem solving.
• Ability to remain organized and positive in ambiguous and rapidly…