Technical Project Manager

Description

• 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.

Qualifications

• 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 Pharmaceutical Good Manufacturing Practices (cGMP) environment
• Familiarity with Pharmaceutical Sciences infrastructure
• Proactive and has a 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.