KBI Biopharma
Manufacturing Associate I / II
USA - NC - Durham - Hamlin Rd · Mid
Sponsorship not specifiedDetected 91 days ago
ERPGMPCell CultureCommunicationOrganizational SkillsMicrosoft OfficeFermentation
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Responsibilities 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.
- Strong written and verbal communication skills are essential.
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.
- Bachelor's degree in a related scientific or engineering discipline with 2-5 years of GMP manufacturing experience
- OR high school diploma with 4-6 years of related GMP manufacturing experience.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of employees of organization.
- Reasoning Abilit y: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to compute rate, ratio, and percent and to draw and interpret graphs.
Nice to have
- 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.
Skills
- MS Office, ERP, EDMS, production equipment software, other.
- The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations.
- Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.
- The noise level in the environment is moderate to high.
- Essential Physical Functions:
- Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed.
- Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed.
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.
- Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.