Manufacturing Associate II

Job Description

 The Manufacturing Associate I/II will 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. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance.

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

Primary 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

Minimum Requirements:

Manufacturing Associate 1:

• 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.

• 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 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 of organization.

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 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.

WORKING CONDITIONS

• Are there particular working conditions associated with this position that should be

noted (i.e., working environment, hours of work, workspace, etc.)

• The 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 ha