Manufacturing Associate I / II

About the Role

Perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. 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.

The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment.

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

• Manufacturing Associate I: 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.
• Manufacturing Associate II: 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.
• 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.
• 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.

Skills

• Basic knowledge of cell culture, fermentation, or purification unit operations (preferred).
• Experience in single-use platform technology (preferred).
• Excellent written and verbal communication skills.
• Proficient in MS Office, ERP, EDMS, production equipment software, and other relevant software.
• Experience with equipment such as 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.

Schedule

Day Shift / 7AM - 7PM / 2-2-3 schedule (12-hour shifts which may include working overnight).

Working Conditions

• Work within a cGMP manufacturing biotechnology facility requiring cleanroom operations.
• Cleanroom operations require donning cleanroom attire when entering cleanroom areas and maintaining good personal hygiene.
• Exposure to mechanical hazards, chemical hazards, electricity hazards, and tripping/falling hazards.
• Moderate to high noise levels in the environment.

Physical Demands

• Standing and sitting for long periods of time during production activities.
• Walking throughout the facility to various locations during production activities.
• Performing activities such as training, document review, and other computer work.
• Lifting and carrying 20kg bags of WFI, Buffer, and Media within the facility.
• Pushing 200kg drums of WFI, Buffer, and Media throughout the facility.
• Performing operations on ladders or step stools.
• Reaching underneath, over, and within production equipment for bioprocess container installation, inspection, and use.
• Fluency in English to communicate effectively over radios, cell phones, and in production locations with machine noise.