Analytical Project Manager

Title: Analytical Project Manager Shift: MON-FRI 8:30AM - 5PM (Onsite) Duration: 1 year Location: Greendale IN 47025 Pay rate $60/hr Education: • Bachelor’s degree in Chemistry, Life Sciences, or a related field (Master’s a plus). Requirements: • Minimum 5 years of experience in related quality and analytical sciences environment.

• Formal project management experience is a must.

• Proven experience with method qualification, transfer, contract lab oversight, and GxP regulations.

• Strong project management skills with the ability to manage complex, cross-functional initiatives.

• Excellent communication, problem-solving, and organizational skills.

• PMP certification or formal project management training is a plus.

Responsibilities: Project Manager: o Lead transfer project to manage all aspects of the outside laboratory vendor transition.

o Develop and execute detailed project plans, timelines, and risk mitigation strategies.

o Coordinate the full transition with both internal stakeholders and external partners.

• Vendor Management: o Serve as the main point of contact between Catalent and both the outgoing and incoming contract analytical organizations.

o Oversee knowledge and method transfer to ensure testing continuity and data integrity.

o Work directly with customers to ensure required approvals are managed through approved change management procedures and progressed with urgency.

• Analytical & Quality Oversight: o Manage transfer of validated analytical methods.

o Coordinate samples being sent in parallel to both vendors during the qualification period.

o Ensure all analytical documentation is reviewed and transferred in compliance with regulatory and customer standards.

o Review and approve protocols/reports, material specifications and initiate required change controls related to the transfer.

• Regulatory Compliance: o Ensure that all activities comply with regulatory requirements.

o Support audit readiness at the new vendor site through follow up of open corrective action plans initiated from corporate qualification inspections.

• Reporting & Communication: o Provide regular updates to senior leadership on project status, risks, and milestones.

o Maintain clear documentation and project history in alignment with quality management systems.

Ref: #558-Scientific