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ProKidney Corp. · 5 hours ago

CMC Technical Training Liaison

United States

Full-time

Remote

Senior Level, Lead/Staff

15+ years exp

ProKidney is a biopharmaceutical company focused on cellular therapy operations. The CMC Technical Training Liaison is responsible for designing and delivering training programs to ensure manufacturing personnel are competent in clinical and commercial cell therapy production, while also providing cross-functional support and ensuring compliance with regulatory standards.

Health CareTherapeutics

No H1B

Responsibilities

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

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

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

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

Qualification

CGMP cellular therapy operationsAseptic techniqueCell processing workflowsTechnical training experienceBiopharmaceutical industry experienceSOPsCross-functional collaborationDocumentationCommunication skillsProblem-solving skills

Required

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

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

Company

ProKidney Corp.

ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.

Founded in 2015

Salem, Oregon, USA

51-200 employees