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Project Coordinator

South San Francisco, CA 94080

Posted: 05/25/2023 Employment Type: Contract Job Category: Project Management Job Number: 567755 Is job remote?: No Country: United States

Job Description


Job Summary

The Process Validation Project Coordinator role will provide support to Technical Development Teams (TDTs) on Process Validation (PV) including project and portfolio analyses and communication of key insights to inform decision-making. He/She/They will work closely with PV stakeholders to plan, maintain, and manage all PV deliverables. The role will be in the Pharma Technical Development Project and Portfolio Management (PTDM).

Job Responsibilities
  • Support the TDTs and ensure on-time Market Applications (MAs) by developing and maintaining PV project schedules and dashboards to track progress.
  • Apply drug/CMC process development knowledge and project management expertise to manage PV deliverables for multiple projects through MA filing and Pre Licensure Inspection (PLI).
  • Lead regular meetings with PV leads to ensure PV studies are on track and keep all relevant stakeholders including the Technical Development Leader (TDL) updated on PV project status, key risks and issues.
  • Provide expertise and guidance to TDTs on PV at project level including continuous improvement of business processes and tools analyses and communication of key portfolio insights to inform decision-making.
  • Act as a valuable member of the overall project team system (e.g. shares best practices and lessons learned).
  • Job Requirements/ Qualifications BS/BA degree in scientific field 2+ years in the pharmaceutical/biotech industry 2+ years drug development project management and process validation experience is preferred
  • Experience and knowledge with Smartsheet, Tableau, and other reporting and tracking tools

Knowledge/Skills/Competencies
  • Knowledge of the drug development process Knowledge and experience with end-to end CMC process development; relevant process validation, regulatory, quality and cGMP expertise is preferred
  • Ability to manage cross-functional teams and development projects and to apply project management skills, methodologies and tools
  • Strong collaborative and relationship-building skills; demonstrated ability to effectively partner and influence internal and external stakeholders
  • Excellent verbal and written communication skills; must be able to effectively communicate/articulate strategy and deliverables to team members and senior management


Pay Rate Range: $25-40/hr. Salary will be commensurate with experience. 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. 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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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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