Process Development & Efficacy (PDE) Manager

About the role

The Process Development & Efficacy (PDE) Manager serves as a bridge between process development and manufacturing operations within the CVPF Manufacturing group. The role provides leadership and expertise in process improvement and innovation, technology transfer and scaling up, automation, troubleshooting, and advanced training to ensure alignment with CVPF’s projects and manufacturing priorities.

Responsibilities

• Manage projects that target the transition of research concepts into robust, compliant, and scalable GMP operations while participating in GMP manufacturing operations.
• Drive continuous improvement, process optimization, and transparent communication of project scope, milestones, and deliverables across CVPF.
• Accurately document and follow Good Documentation Practices for internal and regulatory reporting.
• Resolve problems that occur in the cleanroom, oversee cell processing activity, provide strategic directions for the implementation of novel processing methods and new trials, implement contingency plans for unexpected processing events, and lead new trial initiation activity.
• Collaborate in the design of processing methods and validation of new equipment and manufacturing processes to support tech transfer into the cell processing facility.
• Efficiently manage time and multitask to complete activities for multiple clinical studies at a given time.
• Communicate effectively with internal and external collaborators, vendors, and regulatory personnel to ensure regulatory compliance of manufacturing processes.
• Assist supervisors with compliance audits performed by regulatory bodies and collaborators.

Requirements

• Bachelor’s degree in Biology or related science required, Master’s degree preferred.
• A minimum of 5 years of prior demonstrated cell processing/cell culture GMP expertise is required.
• Cell therapy experience is required.
• Ability to work effectively in a fast-paced environment and consistently meet deadlines is required.
• Demonstrated expertise as an operator and knowledge on GMP cell processing equipment, laboratory techniques, and manufacturing processes required.
• Strong critical thinking skills are essential to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements.

Qualifications

• Bachelor’s degree in Biology or related science required, Master’s degree preferred.
• Minimum of 5 years of prior demonstrated cell processing/cell culture GMP expertise is required.
• Cell therapy experience is required.
• Ability to work effectively in a fast-paced environment and consistently meet deadlines is required.
• Demonstrated expertise as an operator and knowledge on GMP cell processing equipment, laboratory techniques, and manufacturing processes required.
• Strong critical thinking skills are essential to ensure data is accurate, logical, and consistent with institutional and regulatory reporting requirements.

Skills

• Expertise in process development and innovation.
• Knowledge of GMP cell processing equipment and laboratory techniques.
• Experience with automation and troubleshooting.
• Strong communication and collaboration skills.
• Ability to manage multiple clinical studies simultaneously.

Benefits

• Health, life, and flexible spending accounts.
• Tuition assistance for employees and their families.
• Retirement plans including basic, matching, and supplemental plans.
• Time away from work and long-term care insurance.
• Wellness and work-life resources.
• University resources and discounts.
• Flexible work options.
• Home ownership services and adoption assistance.

Pay

$74,500.00 - $100,000.00 Annual Rate

Schedule

Essential University employee position requiring flexibility to work off-shift, additional hours, or on-call hours as needed.