Manufacturing Associate I/II
KBI Biopharma
Summary
12 hours, 7PM-7AM, 2*2*3. The Manufacturing Associate I/II (Nights) is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment.
Job description
Job Responsibilities
- Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
- Document each task involving manufacturing procedures (SR's, EPR's and BR's) following GDP at the time of execution.
- Ensure all items are issued and accounted for during the execution of a record.
- Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
- Participate and be accountable for room 5S.
- Utilize and perform maintenance on equipment per applicable SOP.
Minimum Requirements
- Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline with 0-2 years' experience in related GMP manufacturing operations; or high school diploma with 3-5 years' experience in related GMP manufacturing operations.
- Manufacturing Associate II: Bachelor's degree in a related scientific or engineering discipline with 2-5 years' experience in related GMP manufacturing operations; or high school diploma with 4-6 years' experience in related GMP manufacturing operations.
- Basic knowledge of cell culture, fermentation or purification unit operations is preferred.
- Experience in single-use platform technology is preferred.
- Excellent written and verbal communication skills are required.
- Fluent in English language both reading and writing.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
- Ability to write routine reports and correspondence.
- Ability to solve practical problems and deal with a variety of concrete variables.
- Ability to add, subtract, multiply, and divide in all units of measure.
- Standing and sitting for long periods of time may be required; lifting, pushing, and pulling may be required.
Requirements
- Bachelor's degree in a related scientific or engineering discipline with 0-2 years' experience in related GMP manufacturing operations; or high school diploma with 3-5 years' experience (Associate I)
- Bachelor's degree in a related scientific or engineering discipline with 2-5 years' experience in related GMP manufacturing operations; or high school diploma with 4-6 years' experience (Associate II)
- Excellent written and verbal communication skills
- Fluent in English language both reading and writing
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records
- Ability to write routine reports and correspondence
- Ability to solve practical problems and deal with a variety of concrete variables
- Ability to add, subtract, multiply, and divide in all units of measure
- Basic knowledge of cell culture, fermentation or purification unit operations preferred
- Experience in single-use platform technology preferred
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.