Manufacturing Associate II (Nights)

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

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate II (Nights) in Durham, NC to execute Upstream or Downstream production activities within a GMP environment. The role supports early/late-phase cell culture programs, following SRs, EPRs, BRs, SOPs, and GDP/GxP standards.

The candidate will perform aseptic processing in a cleanroom, document tasks, maintain records, and apply cGMP knowledge. Night shifts required in a fast-paced facility with strict quality controls.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 2–5 years of GMP manufacturing experience.
• High school diploma with 4–6 years GMP manufacturing experience acceptable alternative.
• Experience with cell culture, fermentation or purification unit operations preferred.
• Excellent written and verbal communication skills; ability to work in a fast-paced GMP environment.

Responsibilities

• Manufacture cell culture products per batch records in compliance with quality standards and regulations.
• Perform operations in a cleanroom environment with aseptic processing, including gowning and cleaning procedures.
• Document each task following GDP at the time of execution (SRs, EPRs, BRs).
• Ensure all items are issued and accounted for during execution of a record (SR, EPR, BR).
• Demonstrate understanding of cGMP and participate in room 5S activities.

Skills

Communication skills

Fluent English

Read & write documents

Problem solving

Education

Bachelor’s degree in science or engineering

High school diploma with GMP experience

Tools

MS Office

ERP

EDMS

Job description

Job SummaryNightshift, 7PM-7AM 2-2-3 rotating scheduleThe Manufacturing Associate 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. 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 ResponsibilitiesManufacture 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 RequirementsBachelor’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.Language AbilityFluent 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.Reasoning AbilityAbility 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 AbilityAbility 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.Physical DemandsStanding 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.Computer SkillsMS Office, ERP, EDMS, production equipment software, otherEquipment UseExamples 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.WORKING CONDITIONSThe job requires working 12-hour shifts which may include working overnight. 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. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.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.