As a Project Coordinator, you will drive sample logistics and testing integrity to support critical process validation studies across our global network. In this role, you will work closely with cross-functional technical teams and quality assurance to help deliver life-changing biopharmaceutical products to patients.

The Opportunity:

• Coordinate assigned Process Validation (PV) study samples across technical development teams, internal laboratories, and external contract manufacturing facilities.
• Ensure the integrity and progress of PV studies by meticulously following protocols, preparing samples, coordinating submissions, and accurately entering data.
• Proactively monitor study status, communicate updates to key stakeholders, and guarantee the quality and compliance of all completed work.
• Review PV protocols and reports for accuracy, completeness, and compliance with regulatory guidelines and internal sample testing standards.
• Generate, review, and approve PV data summary tables.
• Perform routine and non-routine analytical testing using techniques such as ELISA, PCR, U/HPLC, CE, LC-MS, and ICP-MS according to established protocols.
• Actively engage in clear and impactful communication across all organizational levels and escalate PV issues at team and department meetings to drive resolution.
• Attend PV and project meetings to represent the analytical operations team and ensure cross-functional alignment.

Who you are:

• You hold a Bachelor's degree in Life Sciences or a related field.
• You have a minimum of 1 year of laboratory experience in biotechnology or a related area, along with knowledge of analytical methodologies.
• You possess familiarity and working knowledge of GxP, including documentation and compliance standards.
• You demonstrate meticulous attention to detail and a strong commitment to delivering high-quality, compliant work.
• You bring strong written and verbal communication, organizational, and problem-solving skills, with a proven ability to manage multiple concurrent priorities.

Preferred:

• Experience in project management within a biopharmaceutical or biotechnology setting.

Relocation benefits are not available for this posting

The expected salary range for this position based in California is $90,100.00 - $167,300.00 USD Annual.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance. 

This position also qualifies for the benefits detailed at the link provided below.