Manufacturing Associate I/II - Downstream

Schedule

Job Description: 7AM‑7PM / 2*2*3 Manufacturing Schedule. The role requires 12‑hour shifts that may include overnight work.

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.

Basic knowledge of cell culture, fermentation or purification unit operations is preferred. Experience in single‑use platform technology is preferred.

Skills

• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a fast‑paced, multi‑tasked environment while maintaining operational efficiency and a positive demeanor.

Qualifications

• Language Ability: 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.
• Reasoning Ability: 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.
• 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.
• Physical Demands: Standing and sitting for long periods of time 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: Work within a cGMP manufacturing biotechnology facility requiring clean‑room operations (donning clean‑room attire, maintaining good personal hygiene); exposure to mechanical, chemical, electrical hazards and tripping/falling hazards; moderate to high noise level.