Manufacturing Specialist I (Contractor)

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.

***This is a 6-month contract role with the possibility of conversion to a permanent role depending on individual performance. This contract role does not include benefits or health insurance.*** 

This role follows a 4 day a week shift schedule working either from 7am-6pm SUN-TUE and 7am-2pm on WED, or 11am-6pm on WED and 7am-6pm THUR-SAT.

The Manufacturing Specialist I plays a vital role in supporting manufacturing operations within the organization, focusing on routine aseptic processing and ensuring compliance with cGMP guidelines. This position involves setting up and operating production equipment, such as control rate freezers and orbital shakers, and completing REACT final product freezing and storage in LN2. 

 Essential Duties & Responsibilities: 

• Coordinate with other job duties while focusing on individual tasks without training others. 

• Participate in aseptic processing of in-house solutions according to current Good Manufacturing Practices (cGMPs). 

• Prepare cleaning solutions for sanitizing cleanrooms following approved procedures. 

• Prepare biopsy and product shippers, ensuring proper documentation. 

• Maintain and stock the clean room environment to ensure it remains below alert level limits by adhering to established procedures. 

• Set up and operate production equipment such as control rate freezers and orbital shakers as needed. 

• Assist in daily manufacturing support activities including vial retrieval, QC sample submission, and freezing in-process cells. 

• Manage cleaning and upkeep of GMP suites and surrounding areas, including routine gowning rooms, biosafety cabinets, and cabinets. 

• Complete Good Manufacturing Practice (GMP) documentation, including batch records, logbooks, and forms, in compliance with Good Documentation Practices (GDP). 

• Understand and comply with all relevant safety policies, rules, and regulations. 

• Perform procedures according to written guidelines and identify deviations from accepted practices. 

Secondary Responsibilities and Functions: 

• Monitor temperatures, material expirations, and calibration of equipment. 

• Assist in data gathering efforts as directed. 

• Provide support for material qualification and process development as required. 

• Perform other duties as assigned. 

Minimum Qualifications:  

• Education/Training: AS/BS in Biotechnology, Biology, Chemistry, or related field preferred, but not required; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with relevant experience. 

• Experience: 0+ years of relevant experience in GMP manufacturing or a related field preferred, but not required. 

• Skills/Abilities: Ability to exercise judgment within defined procedures, follow production schedules and SOPs, and understand the importance of compliance with cGMPs. Proficiency in aseptic gowning and working independently or in a team setting is essential. Strong computer skills, including Microsoft Office, along with organizational, record-keeping, and time management abilities, are required. 

• Other: Good eye/hand coordination, effective written and oral communication skills, a team-oriented approach, and a strong work ethic are critical for success in this role. 

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.