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Analytical Project Manager
133 601 Rudolph Way Greendale, IN 47025 US
Job Description
The Analytical Project Manager will lead the initiation of the end-to-end transfer of outsourced analytical and microbial testing services from an existing contract testing lab to a new vendor. This detail-oriented, critical role ensures continuity of analytical and technical services, compliance with regulatory standards, and seamless integration of the new vendor into our quality systems and processes.
II. Specific Tasks, Duties and Responsibilities: • Project Management: 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 company 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.
III. Essential Skills and Experience:
Education or Equivalent: • Bachelor’s degree in Chemistry, Life Sciences, or a related field (Master’s a plus).
• Minimum 5 years of experience in related quality and analytical sciences environment.
• Formal project management experience is a must. Knowledge/Skills Requirements: • 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.
IV. Dimensions of Position:
This is a project driven, contract role that will oversee the full vendor transfer process from initiation to completion.
Pay Rate Range: $45-60/hr depending on experience
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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