Manufacturing Associate I

Job Summary:

The Manufacturing Associate I/II is responsible for the execution of Upstream or
Downstream production activities for early and late-phase Cell Culture programs
within a GMP environment.

The Manufacturing Associate I/II must follow the instructions depicted in SR’s,
EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted
following Good Manufacturing Practices (GMP), Good Documentation Practices
(GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT).
The candidate will maintain a sense of ownership of the production processes,
manufacturing environment and facility. They will be exposed to various unit
operations including 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; as well as to analytical tools and general biotechnology auxiliary
equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolality
meters). Following task execution, the Manufacturing Associate I/II will review the
executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance.

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

Job Requirements:

Education:

• Manufacturing Associate I - Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations; or high school diploma with 3-5 years’ experience in related GMP manufacturing operations.
• Manufacturing Associate II - Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations

Knowledge / 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.

Computer Skills:

• Knowledge or and experience using MS Office, ERP, EDMS, production equipment software

Equipment Use:

• Knowledge of and experience using equipment - Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmo