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Project Coordinator

South San Francisco, CA 94080

Posted: 05/23/2023 Employment Type: Contract Industry: Product Development & Project Management Job Number: 11258 Pay Rate: $40.00 - $42.00

Job Description


Our client is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.


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

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.

Meet Your Recruiter

Shannon Chamberlin
Professional Recruiter, Account Manager

As a recruiter at Compass, Shannon is passionate about helping people. She finds her own personal fulfillment in guiding candidates on their career journey. Her candidates always feel very supported and she is the ultimate cheerleader when you find the right fit at a great company.

When Shannon isn’t working, she enjoys time with her family and weekends full of sporting events for her boys. She enjoys travel, time with friends and helping children with learning disabilities.

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