Technical Project Manager

Role Summary

Technical Project Manager lead and manage moderately to complex technology transfer and clinical supply projects within sterile injectable manufacturing. 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. Serve as a technical leader with strong project management capabilities, collaborating cross-functionally to ensure timely and compliant delivery of manufacturing solutions.

Responsibilities

• 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

• Minimum: bachelor's degree with at least 4 years of experience; OR master's with at least 2 years; OR PhD with 0+ years; OR associate's with 8 years; OR high school diploma with 10 years of relevant experience.
• Strong understanding of cGMP, ICH guidelines, and regulatory frameworks (FDA, EMA).
• Strong analytical and problem-solving skills.
• Excellent communication, technical writing, and stakeholder engagement skills.

Preferred Qualifications

• 5+ years of experience in sterile injectable manufacturing or aseptic processing.
• 3+ years of hands-on project management experience in regulated manufacturing or pharmaceutical environment with cross-functional leadership.
• Experience with technology transfer, clinical trial material production, and validation lifecycle management.
• Project Management Professional (PMP) certification or equivalent strongly preferred.
• Proficiency with project management platforms and tools (e.g., MS Project, Planner).

Skills

• Technical writing
• Stakeholder engagement
• Process characterization
• Regulatory compliance (cGMP, ICH, FDA/EMA)
• Project scheduling and budgeting
• Cross-functional leadership

Education

• Not specified beyond degree requirements in Qualifications

Additional Requirements

• Requires regular onsite presence at the McPherson, KS facility.
• Ability to work flexible hours including occasional weekends or holidays.
• Physical requirements and other duties as described are inherent to the role.