CMC Technical Training Liaison

Position Summary

The Chemistry Manufacturing and Control (CMC) Technical Trainer Liaison is a subject matter expert in cGMP cellular therapy operations, aseptic technique, and closed/open processing in a biological safety cabinet (BSC). This role is responsible for designing, delivering, and maintaining training programs that ensure manufacturing personnel are fully competent in executing clinical and commercial cell therapy production. The successful candidate brings deep hands-on experience in aseptic manipulation, cell processing workflows, and batch record execution within a regulated environment. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of cell therapy production (including the cross functional roles of manufacturing, MSAT, PD, QC and quality assurance), demonstrated with previous experience. The position is required to develop and provide documented evidence supporting the manual portions of the Rilparencel Manufacturing Control Strategy.  The position may require participation, review and/or authorship of CMC-related GMP documents, protocols, SOPs, etc., such as tech transfer protocols, validation protocols, risk assessments, FMEA, etc.  This is an onsite position (Winston-Salem) with minimal travel to Morrisville NC site.

This role partners closely with Manufacturing, MSAT, and Quality Assurance to ensure consistent operational readiness, training compliance, and continuous improvement of technical training systems.

Responsibilities

CMC Training Program Development

• Develop, implement, and sustain competency-based technical training for cell therapy manufacturing and other CMC departments as required, including:
• In collaboration with QA Learning department, the development of curricula and training matrices for technical competency-based training on the manual aseptic manufacturing process in compliance with the manufacturing control strategy.
• Cell isolation, expansion, harvest, and cryopreservation workflows.
• Assess process requirements for batch execution and review to ensure completeness and accuracy from operators.
• Open and Closed system processing (e.g., LOVO, Sepax C-Pro, Xuri, G-Rex, bioreactors, etc.).
• Manual process manipulation in compliance with approved contamination control principles and environmental monitoring requirements.
• Deliver hands-on training for manufacturing personnel on execution of the manufacturing process.
• Perform Train-the-Trainer qualification for manufacturing department trainers.

Qualifications & Compliance

• Ensure compliance with training requirements and provide documented evidence to ensure training records are complete and up to date, including:

• Conduct operator assessments, OJT approvals, and procedural compliance.
• Perform training, observation, and qualification of operators in the execution of the manufacturing process, in accordance with oversight/training program documentation requirements to ensure compliance with manufacturing and aseptic process control requirements.
• Ensure training content complies with FDA/EMA expectations, and internal quality standards.
• In compliance with Quality System requirements, provide documented evidence of training, qualification and competency of operators in the execution of the manufacturing process.

Continuous Improvement & Technical Expertise

• Ensure ongoing process improvements are identified and implemented, for example:
• Serve as an on-floor coach and subject matter expert to support manufacturing process execution.
• Identify skill gaps, training risks, and improvement opportunities in manufacturing operations.
• Collaborate with QA, PD, MS&T and MFG to ensure alignment between training, SOPs, batch records, and process changes.
• Develop and provide necessary training for Technical Transfers or Action Items identified within the Quality System.
• Support deviation investigations related to human performance or techniques linked to batch records, SOPs, Work Instructions and/or Manufacturing Process Control, and identify improvement opportunities to ensure right first-time execution; implement corrective process training as needed.

Cross Functional Support

• Provide cross-functional support to Manufacturing, MSAT, and PD by:
• Authoring or reviewing training-related documentation (SOPs, job aids, qualification checklists, training curricula).
• Assisting with process transfers, and manufacturing scale-up from a training readiness perspective.
• Communicating effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments.

Qualifications

• Bachelor's degree in sciences or related field
• 15+ years of relevant biopharmaceutical industry experience with 10+ years of cell therapy, biologics manufacturing or aseptic processing.
• Must have a proven track record of effective collaboration with cross-functional CMC teams.
• Previous experience in QC, analytical development, process development and/or manufacturing of biologics/cell & gene therapy
• Prior background in CMC development at a biotech/pharma company focused on cell therapy.
• Must have previous direct technical training experience with cell-based medicinal products.
• Experience with new facilities, cleanroom startup, comparability, FDA submissions, tech transfer, batch analysis
• Must be a “hands-on” and active contributor in all aspects

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.