Biopharma Process Validation Coordinator

Genentech; South San Francisco (CA); On-site; USD 90,000 - 167,000; Full time

Job summary

Genentech seeks a Project Coordinator to drive PV sample logistics and testing integrity for global process validation studies. You will collaborate with cross-functional technical teams and QA to ensure high-quality, compliant work that supports life-changing biopharmaceutical products.

Your responsibilities include coordinating PV samples, monitoring study progress, and preparing data while adhering to GxP guidelines. Strong communication and organization are essential.

Qualifications

• Bachelor's or higher in Life Sciences or related field.
• At least 1 year of laboratory experience in biotechnology or related area.
• Familiar with GxP, including documentation and compliance standards.
• Strong attention to detail and commitment to high-quality, compliant work.
• Excellent written and verbal communication, organization and problem-solving skills.

Responsibilities

• Coordinate PV study samples across technical development teams, internal labs and external CMOs.
• Ensure PV studies progress by following protocols, preparing samples, coordinating submissions and data entry.
• Monitor study status, communicate updates to stakeholders, ensure quality and compliance.
• Review PV protocols and reports for accuracy and regulatory compliance.
• Generate, review and approve PV data summary tables.
• Perform routine and non-routine analytical testing (ELISA, PCR, U/HPLC, CE, LC-MS, ICP-MS) per protocols.
• Communicate across organizational levels and escalate PV issues as needed.
• Attend PV and project meetings to represent analytical operations and align cross-functionally.

Education

Bachelor's degree in Life Sciences or related field

Laboratory experience in biotechnology or related area

Job description

Genentech seeks a Project Coordinator to drive PV sample logistics and testing integrity for global process validation studies. You will collaborate with cross-functional technical teams and QA to ensure high-quality, compliant work that supports life-changing biopharmaceutical products.

Your responsibilities include coordinating PV samples, monitoring study progress, and preparing data while adhering to GxP guidelines. Strong communication and organization are essential.