Manufacturing Associate I - Nights

Night shift position (7PM-7AM) on a 2×2×3 rotating manufacturing schedule.

About the role

Perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Execute tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Maintain process ownership, facility upkeep, and thorough documentation review.

Responsibilities

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• 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.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• 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.
• Fluent in English (reading and writing).
• Ability to read and interpret documents such as safety rules, operating instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of employees.
• Ability to solve practical problems with limited standardization.
• Ability to interpret instructions in written, oral, diagram, or schedule form.
• Basic math skills: add, subtract, multiply, divide in all units of measure, compute rate/ratio/percent, draw and interpret graphs.

Physical Demands

• Standing and sitting for long periods.
• Lifting, pushing, and pulling equipment.
• Use of ladders when setting up bioreactors.

Working Conditions

• 12-hour overnight shifts in a cGMP manufacturing biotechnology facility.
• Clean room operations requiring donning clean room attire and maintaining good personal hygiene.
• Exposure to mechanical, chemical, and electrical hazards; tripping and falling risks.
• Moderate to high noise levels.