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CDMO Operations Project Manager in Houston, TX at Lucas Group

Date Posted: 2/5/2019

Job Snapshot

Job Description

Our client, a CDMO in the greater Houston area, seeks a Project Manager with CDMO experience.  Relocation assistance provided.  The Project Manager will be responsible for the planning and delivery of programs from the point of contract signature to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Project Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission.

Essential Functions:

  • Onboard new customer programs with the Sales Team to transition to become the primary liaison for program planning and execution.
  • Lead the planning and execution of programs.
  • Oversee the general day-to-day execution of project activities and planning to ensure on time completion of project tasks and deliverables.
  • Identify program delivery risks and mitigations and ensure program team, site leadership team, and customer are appropriately informed.
  • Ensure financial activities and program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
  • Ensure all Contract elements (BSA-MSA, Quality Agreement, Price and Payment Schedule, SOW) are completed.
  • Develop and maintain the Master Project Plan (MPP).
  • Partner with functional teams (QC, QA, PD, Manufacturing, etc.) to ensure that MPP revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
  • Work closely with Process Development, Manufacturing, Engineering, Quality Control and Quality Assurance to reduce time to clinic or market, improve ease of manufacturing, and reduce costs when compared with existing platform products while achieving and maintaining full compliance (cGMP, Safety and Environmental).

Required Qualifications:

  • Bachelor’s degree preferably in Engineering, Microbiology, Chemistry, Biochemistry, Business, or related field, and 5+years’ relevant project management experience.
  • Proven leadership skills.
  • Experience in a world class process development or manufacturing environment utilizing best practice methodologies such as Lean Manufacturing, Six Sigma, 5S, QbD, DFM, etc.
  • Experience in Technology Transfer and Process Development.
  • CDMO industry experience required.

Job ID: 1552952