Manufacturing Assistant
KBI Biopharma
Summary
This position operates on a 2-2-3 schedule with the hours 7:00 am-7:30 pm. The Manufacturing Assistant position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non-routine cleanings and maintains gowning supplies for the locker rooms and gowning rooms at the CMF GMP facility to support continuous manufacturing operations. This position requires a shift schedule and gowning into a clean room environment. This position requires PPE.
Job description
Position Summary
This position operates on a 2-2-3 schedule with the hours 7:00 am-7:30 pm. The Manufacturing Assistant position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non-routine cleanings and maintains gowning supplies for the locker rooms and gowning rooms at the CMF GMP facility to support continuous manufacturing operations. This position requires a shift schedule and gowning into a clean room environment. This position requires PPE.
Must be able to document, record activities in electronic systems and comply with regulatory requirements, cGMP’s, Policy Documents, and SOP’s. Must be able to maintain training at 95% or greater.
Must always wear proper PPE and follow all safety guidelines outlined by the SOP and site policies when working in the facility.
Must be able to perform general tasks as assigned by the supervisor to support manufacturing, i.e., staging materials, discarding waste, moving equipment, and other general cleanroom tasks.
Position Responsibilities
- Performs and maintains manufacturing facilities by routine/non-routine cleanings (daily, weekly, and monthly cleanings)
- Handling an discarding of hazardous and nonhazardous waste
- Computer: includes maintaining training and job-related functions
- Order and stock general supplies in the manufacturing production areas
- Perform other various tasks as assigned by the supervisor/manager
Position Requirements
- Manufacturing Assistant I: High School diploma or Associates Degree with 0+ years of experience. Bioworks certificate preferred.
- Manufacturing Assistant II: High School diploma or Associates Degree with 18+ months of experience. Bioworks certificate preferred
Requirements
- High School diploma or Associates Degree
- 0+ years of experience
- Bioworks certificate preferred
- Ability to work in a clean room environment
- Ability to follow strict safety and regulatory protocols
- Maintain high training compliance
Benefits
- Annual bonus structure
- Medical, Dental & Vision
- Paid PTO
- Paid holidays
- Sabbatical program
- 401(k) matching
- Employee recognition programs
Company overview
KBI Biopharma is an award-winning global contract development and manufacturing organization (CDMO) that provides fully integrated, accelerated drug development and biologics manufacturing services to pharmaceutical and biotechnology companies worldwide. Founded in 1996 and now part of JSR Life Sciences, KBI has established itself as a next-generation CDMO specializing in complex biologics. The company serves over 500 client partners and has supported the advancement of more than 160 drug candidates from preclinical stages to market, including the manufacture of ten commercial products. KBI's comprehensive service portfolio includes cell line development, process development, analytical services, formulation development, and clinical and commercial cGMP manufacturing for both mammalian and microbial programs. With strategically located facilities across the United States and Europe, KBI leverages world-class analytical capabilities and proprietary platforms like SUREtechnology™ and PUREplatform™ to deliver personalized, accelerated solutions for biopharmaceutical development. The company is recognized for its scientific excellence, quality manufacturing, and commitment to helping clients bring innovative medicines to patients faster.