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Jobs · Analyst · North Carolina

Manufacturing Associate II (Nights)

KBI Biopharma · Durham, NC · 2 mo ago
AnalystFull-time

Nightshift role on a 2-2-3 rotating schedule (7 PM – 7 AM).

About the role

The Manufacturing Associate II (Nights) executes Upstream or Downstream production activities for early- and late-phase Cell Culture programs in a GMP environment. The role follows instructions in Standard Records (SRs), Equipment Production Records (EPRs), Batch Records (BRs), SOPs, and forms while adhering to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP), including “Right the First Time” (RFT). The candidate maintains ownership of production processes, the manufacturing environment, and the facility.

Exposure includes unit operations such as 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. The role also involves working with analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/conductivity/osmolality meters). After task execution, the Manufacturing Associate reviews production records (SRs, EPRs, BRs) to ensure GxP compliance.

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 (SRs, EPRs, BRs) following GDP at the time of execution.
  • Ensure all items are issued and accounted for during the execution of a record (SR, EPR, BR).
  • Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
  • Participate in and be accountable for room 5S initiatives.
  • Utilize and perform maintenance on equipment per applicable SOP.

Requirements

  • Bachelor’s degree in a related scientific or engineering discipline with 2–5 years’ experience in GMP manufacturing operations; or high school diploma with 4–6 years’ experience in 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.
  • Energetic, motivated, and dynamic individual.
  • Organized and able to focus in a fast-paced, multi-tasked environment while maintaining operational efficiency and a positive demeanor.

Skills

  • Language Ability: Fluent in English (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.
  • Reasoning Ability: Ability to solve practical problems and deal with concrete variables in situations with limited standardization. Ability to interpret 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.
  • Computer Skills: Proficiency in MS Office, ERP, EDMS, production equipment software, and other relevant systems.
  • Equipment Use: Experience with Biosafety Cabinets, Incubators, Single-Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling Systems, Peristaltic Pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, and other lab, production, and office equipment.

Physical Demands

  • Standing and sitting for long periods may be required.
  • Lifting, pushing, and pulling may be required for stocking and movement of equipment.
  • Use of a ladder may be required when setting up bioreactors.

Working Conditions

  • 12-hour night shifts on a 2-2-3 rotating schedule.
  • Work within a cGMP manufacturing biotechnology facility, including cleanroom operations requiring donning cleanroom attire and maintaining good personal hygiene.
  • Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling hazards.
  • Moderate to high noise levels in the environment.

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