Process Validation Project Manager

Our Customer has been committed to improving lives since the company was founded in 1896. Today, they create innovative medicines and diagnostic tests that help millions of patients globally. They are the world's number 1 in biotech with 17 biopharmaceuticals on the market. Over half of the compounds in their product pipeline are biopharmaceuticals, enabling them to deliver better-targeted therapies.

We are seeking a Process Validation Project Manager on a contract basis to help support our Customer's business needs. This 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. The candidate will work closely with PV stakeholders to plan, maintain, and manage all PV deliverables. This role will be in the Pharma Technical Development Project and Portfolio Management.

What You’ll Do:

• Support the TDTs and ensure on-time Market Applications by developing and maintaining PV project schedules and dashboards to track progress
• Apply drug or CMC process development knowledge and project management expertise to manage PV deliverables for multiple projects through MA filing and Pre Licensure Inspection
• Lead regular meetings with PV leads to ensure PV studies are on track and keep all relevant stakeholders including the Technical Development Leader updated on PV project status, key risks, and issues
• Provide expertise and guidance to TDTs on PV at the 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)

Must Haves:

• 2+ years in the pharmaceutical/biotech industry
• 2+ years of a drug development project management and process validation experience is preferred
• Ability to manage cross-functional teams and development projects and to apply project management skills, methodologies, and tools
• Ability to demonstrate effective partnership and influence internal and external stakeholders
• Strong collaborative and relationship-building skills
• Excellent verbal and written communication skills; must be able to effectively communicate/articulate strategy and deliverables to team members and senior management
• Strong working knowledge and experience with Smartsheet, Tableau, and other reporting and tracking tools
• 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

Education:

• A Bachelor's degree in a scientific field is required

Hours & Location:

• M-F, 40 hours/week. This role will be onsite at our Customer’s South San Francisco, CA. There is no remote capability for this role

All applicants applying for U.S. job openings must be legally authorized to work in the United States and are required to have US residency at the time of application.

Please note: In order to create a safe, productive work environment, our client is requiring all contractors to be fully vaccinated (regardless of work location) according to the CDC guidelines (please inform your employer if you need a medical or religious exemption). Prior to onboarding, contractors will be required to attest that they are fully vaccinated.

Perks are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements)

Health Benefits: Medical, Dental, Vision, 401k, FSA, Commuter Benefit Program

The salary range for this position is $48.85 - $76.76 per hour.