The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations.

Essential Duties & Responsibilities:

• Lead and participate in 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 other team members as needed.
  • Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.
  • Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.
  • Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.
  • Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).
  • Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.
  • Perform and support investigations into deviations, incidents, and process improvements.
  • Lead efforts in process development, qualification, and validation activities as needed.
  • 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.

Secondary Responsibilities:

• Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.
  • Provide guidance and support for continuous process improvement initiatives.
  • Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.
  • Perform other duties as assigned to support and improve manufacturing operations.

Minimum Qualifications:

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.
  • Experience: Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.
  • Skills/Abilities: 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.
  • Other: 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.

The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines. This position requires a high level of expertise in performing complex aseptic processing of in-house solutions, preparing materials and kits, managing GMP areas, and ensuring stringent compliance with Standard Operating Procedures (SOPs). The role also involves actively participating in document revision, providing training and mentoring to junior staff, and assisting in deviation and CAPA (Corrective and Preventive Action) investigations. As a senior position, the Specialist III will be a key contributor to maintaining high standards of GMP documentation and will work with a high degree of accountability and independence to ensure the continuous improvement of manufacturing operations.

Key Responsibilities:

Aseptic Processing & GMP Maintenance:

• Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality.
• Participate in material kit preparation, ensuring alignment with Good Documentation Practices (GDP) and cGMP standards.
• Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices.
• Ensure proper documentation of cleaning and maintenance activities, including batch records and logbooks, in strict adherence to GMP and GDP standards.
• Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards.

Documentation & Compliance:

• Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices.
• Complete and ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, in compliance with GDP.
• Participate in internal and external audits, supporting the team in ensuring compliance with regulatory bodies, including the FDA.
• Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary.

Training, Mentoring & Leadership:

• Mentor and train new and less experienced staff on manufacturing processes, GMP procedures, and safety protocols.
• Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations.
• Assist in training initiatives for the broader team, focusing on aseptic techniques, GMP best practices, and proper documentation practices.
• Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects.

Material & Equipment Management:

• Conduct routine cycle counts in cleanrooms to ensure accurate inventory levels and prevent shortages.
• Manage and execute routine transactions in the ERP system, including material requisitions, production tracking, and inventory management.
• Ensure proper handling, storage, and documentation of materials and equipment to prevent contamination and maintain compliance with GMP standards.

Safety & Process Improvement:

• Promote and enforce adherence to safety policies and procedures to prevent workplace accidents and injuries.
• Proactively identify deviations from SOPs and GMP standards and take immediate corrective action.
• Assist in the implementation of Corrective and Preventive Actions (CAPAs), identifying root causes of issues and ensuring solutions are effectively put in place.
• Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance.

Collaboration & Data Collection:

• Collaborate with cross-functional teams, including production, quality assurance, and engineering, to ensure seamless operations and continuous adherence to manufacturing standards.
• Assist in data collection efforts for troubleshooting, CAPA investigations, and other manufacturing-related tasks.
• Provide insights and contribute to the development of new procedures, technologies, and improvements within manufacturing operations.

Secondary Responsibilities:

• Perform additional tasks as needed to support the manufacturing team and ensure the smooth operation of the manufacturing process.
• Contribute to data analysis and reporting efforts as directed.

Minimum Qualifications:

Education/Training:

• AS/BS in Biotechnology, Biology, Chemistry, or a related field; a Science-related discipline is preferred.
• High School Diploma or equivalent may be considered with relevant experience.
• Certification in aseptic techniques or GMP training is preferred.

Experience:

• 2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field.
• Demonstrated experience with aseptic techniques, GMP cleaning, and working in a regulated environment.
• Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred.

Skills & Abilities:

• Strong knowledge of cGMP and GDP standards, with the ability to follow production schedules and SOPs.
• Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment.
• High level of attention to detail and the ability to manage multiple tasks and priorities effectively.
• Strong computer skills, including proficiency in Microsoft Office, ERP systems, and other relevant software tools.
• Excellent organizational, record-keeping, and time management abilities.
• Ability to communicate effectively, both written and verbally, with a diverse team and in cross-functional environments.
• Ability to exercise independent judgment, solve problems, and identify improvements.

Other:

• Strong eye/hand coordination and commitment to maintaining a high quality of work.
• A leadership mindset with the ability to mentor and train others.
• Willingness to wear protective clothing and equipment as required in a GMP environment.
• Ability to lift and move objects up to [specific weight, e.g., 25 pounds].

Physical Requirements:

• Ability to stand for extended periods and perform repetitive tasks.
• Capability to lift and move objects up to [specific weight, e.g., 25 pounds].
• Willingness to wear protective clothing and equipment as required.

Position Summary:

As an Sr. Manager, Process Excellence, you will play a strategic role in driving efficiency, compliance, and transformation within Operational Excellence. You will guide cross-functional teams across manufacturing operations, fostering a culture of innovation, continuous improvement, and operational excellence. Leveraging your expertise in GMP compliance, process improvement methodologies, and digital manufacturing technologies, you will elevate manufacturing performance and drive strategic initiatives.

Responsibilities:

• Develop and implement innovative process improvement strategies, leveraging digital technologies and GMP best practices to enhance efficiency and compliance.
• Collaborate with cross-functional teams to assess and execute strategies that enhance process efficiency, reduce costs, and improve overall performance, align to organizational objectives.
• Develop and maintain comprehensive process documentation (SOPs, process maps, work instructions, RACI).
• Lead change management initiatives to support adoption of new processes and technologies.
• Stay current on industry advancements, best practices, and emerging trends in manufacturing operations management.
• Proactively identify opportunities for optimization, cost reduction, and value creation.
• Identify opportunities for digital transformation within manufacturing operations (automation, data analytics, and tool integration).
• Utilize data analytics and KPIs to monitor performance and identify trends, compliance issues, and improvement opportunities.
• Produce clear reports and insights for senior leadership to inform strategic decisions and provide visibility into manufacturing performance.
• Communicate effectively at all levels, translating complex concepts and strategies into actionable objectives.
• Foster a culture of openness, transparency, and collaboration across manufacturing operations.

Qualifications:

• Bachelor’s degree in Operations Management, Engineering, Life Sciences, or related field. Master’s degree or relevant certifications (e.g., Lean Six Sigma, PMP, CQE) preferred.
• Minimum of 5 years of experience in manufacturing operations management, GMP compliance, process improvement, or related roles in a regulated environment.
• Strong knowledge of GMP regulations and regulatory compliance requirements.
• Expertise in Operational Excellence and continuous improvement methodologies (Lean, Six Sigma, VSM, DMAIC).
• Proficient in process documentation, mapping, and RACI frameworks (SOPs, WI).
• Familiarity with autologous aseptic manufacturing and cleanroom operations.
• Proficiency with manufacturing digital technologies (ERP, MES, LIMS) and process analytics tools (Excel, Visio, data visualization software).
• Knowledge of Chain of Identity/Chain of Custody is a plus.
• Track record of inspection readiness and remediation is a plus.
• Strong analytical, strategic thinking, and change management skills.
• Executive presence with excellent communication skills across all organizational levels.