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ProKidney Corp. · 3 months ago

Mfg Cell Processing Specialist 3 (Contract)

Winston-Salem, North Carolina, United States

Contract

Onsite

Mid, Senior Level

4+ years exp

ProKidney is a company focused on advanced manufacturing operations, and they are seeking a Manufacturing Cell Processing Specialist 3 to support cell processing activities while ensuring compliance with cGMP guidelines. The role involves operating production equipment, mentoring team members, and driving continuous improvement in manufacturing processes.

Health CareTherapeutics

No H1B

Responsibilities

Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards

Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to team members

Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and preventive maintenance

Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to procedures and maintaining quality standards

Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance

Lead routine cycle counts and ensure accurate inventory tracking and control

Execute transactions within the ERP system, including material requisitions and production tracking

Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP)

Lead investigations into deviations and Corrective and Preventative Actions (CAPA) efforts, compiling data and information as required

Provide mentorship and training to junior team members in cell processing techniques, procedures, and cGMP compliance

Drive continuous improvement, incident investigations, and deviation resolutions

Perform and support investigations into deviations, incidents, and process improvements

Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment

Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards

Perform material qualification tests to qualify lots of incoming manufacturing material

Support process development and validation activities as needed

Assist in data collection, analysis, and reporting for process optimization and regulatory submissions

Perform other duties assigned to support and improve manufacturing operations

Qualification

CGMP complianceCell processingBiotechnology manufacturingERP systemsSOP implementationProblem-solvingTeam-orientedEffective communicationTime management

Required

AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may be a substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience

Preferred minimum 4-6 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 2-3 years of proven expertise in a cGMP-regulated environment

Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs

Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills

Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role

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