Manufacturing Team Lead

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

• Leads the day to day operations of the manufacturing team
• Initiation of manufacturing deviations, CAPAs, and CCRs as required
• Lead/manage deviation and CAPA investigations, compiling data/information related to internal investigations as required
• Subject Matter Expert (SME) on all manufacturing processes
• Able to quickly and efficiently troubleshoot issues as they arise and direct junior staff members on immediate corrective actions
• Completes manufacturing batch record review for all manufacturing processes
• Qualified to participate in the aseptic processing of in-house made solutions as well as all patient processes according to cGMPs
• Reads, understands, and follows Standard Operating Procedures (SOPs)
• Assists in the selection and hiring of new staff
• Manages the training and mentoring of new staff
• Performs personnel scheduling to adequately manage personnel resources required for manufacturing processes ensuring manufacturing is completed efficiently
• Authors and revises approved documents as required including SOPs, batch records, and/or MS forms
• Perform routine transactions with the ERP system including, but not limited to material requisitions, production tracking, updating work orders and production BOMs, etc.
• Complete GMP documentation, including batch records, logbooks, forms, etc. according to GDP
• Support the maintenance of the clean room environment in order to maintain the cleanroom below alert level limits by following established procedures
• Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
• Ensure that all team members comply with safety rules and regulations.
• Able to perform procedures according to written guidelines and recognize a deviation from accepted practice.
• Relies on instructions and pre-established guidelines to perform the functions of the job.
• Leads and directs the work of others. A wide degree of creativity and latitude is expected. May provide consultation on projects and is considered to be a high-level contributor/specialist.
• Participation in internal and external audits as required
• Compiling and analyzing data, preparing reports, and making recommendations for changes and/or improvements.
• Routine logbook review
• Process development support as needed

Education/Training:

• AS/BS in Biotechnology, Biology, Chemistry, or equivalent
• Preferred area of study:  Science related discipline
• High School Diploma or Equivalent may be considered with relevant experience

Experience:

• Minimum 4-5 years relevant experience

Skills/Abilities:

• Must be knowledgeable of various commonly used biological processing techniques including cell culture, ultra-filtration and column chromatography.
• Must have a thorough knowledge of cGMP facilities and cGMP requirements.
• Must have an advanced knowledge of Microsoft applications, especially Word, Excel, etc.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
• Must be able to exercise critical thinking and be able to troubleshoot when unexpected events occur
• Ability to exercise judgment within defined procedures and practices to determine appropriate action.
• Good eye/hand coordination
• Written and oral communication, team oriented, strong work ethic

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.