KBI
Manufacturing Associate I/II - Solution Prep (Nights)
USA - NC - Durham - Hamlin Rd · Mid
Sponsorship not specifiedDetected 8 days ago
GMPCell CultureCommunicationOrganizational SkillsFermentation
About the role
- include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy.
- The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling.
Responsibilities
- Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance.
- Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
- Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
- Maintain and uphold 5S standards in the manufacturing environment.
- Operate and perform maintenance on equipment per applicable Standard Operating Procedures.
Requirements
- Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience
- OR high school diploma with 3-5 years of related GMP manufacturing experience.
- Ability to read and interpret
- Ability to write routine reports and
- Ability to speak effectively before groups of employees of organization.
- Ability to solve practical problems and deal with a variety of concrete variables in
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology.
Skills
- Strong written and verbal communication skills are essential.
Benefits
- Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Company info
- I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
Equal opportunity
- KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.