KBI: US - Manufacturing Associate I/II

KBI Biopharma; Durham (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

KBI Biopharma in Durham, NC is seeking a Manufacturing Associate I/II to execute upstream or downstream production activities within a GMP environment. You will follow SRs, EPRs, BRs and SOPs, ensuring GDP/GLP compliance and Right the First Time execution.

The role covers aseptic processing, cell culture operations, chromatography, ultrafiltration and related unit operations, with emphasis on meticulous documentation and teamwork. Fluent English required.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline or equivalent GMP experience.
• GMP knowledge and ability to follow SRs, EPRs and BRs with GDP/GLP compliance.
• Excellent written and verbal communication; strong documentation skills.

Responsibilities

• Manufacture cell culture products per batch records in compliance with quality standards.
• Perform aseptic operations in a cleanroom with proper gowning and cleaning procedures.
• Document tasks in SRs, EPRs and BRs following GDP at the time of execution.
• Ensure items are issued and accounted for during production records.
• Apply understanding of cGMP and related responsibilities to tasks.
• Participate in room 5S and maintain equipment per SOP.
• Operate and maintain production equipment and related tools.

Skills

GMP knowledge

Documentation accuracy

Aseptic technique

English fluency

Attention to detail

Education

Bachelor's degree in a related scientific or engineering discipline

High school diploma with GMP manufacturing experience

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

Job Description

JOB SUMMARY

*12 hours, 7AM-7PM, 2*2*3

The Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment.

The Manufacturing Associate I/II must follow the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT).

The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to various unit operations including media/buffer preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as to analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolality meters). Following task execution, the Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance.

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 (i.e. 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 (i.e. SR, EPR and BR)
• 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.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• 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 speak effectively before groups of employees of organization.
• 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.
• 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.
• Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors.
• MS Office, ERP, EDMS, production equipment software, other
• Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, other lab, production, and office equipment.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

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. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.