JOB DESCRIPTION:

This position is on a 2-2-3 shift, Day Shift (7am-7pm)

The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream processing for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest). The Manufacturing Associate will have a working knowledge of upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment). Additionally, the manufacturing associate will have knowledge of general bioprocessing equipment such as filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies (disposable bags, sterile tubing welders, tubing sealers). Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance.

The Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. Staff will work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure startup and ongoing manufacturing operations are successful, reliable, and compliant. A proven Manufacturing Associate will demonstrate the following qualities: learning agility, orientation toward action, results driven, team player, strong attention to detail, and superior integrity and accountability.

JOB RESPONSIBILITIES:

• Manufacture bulk intermediates and drug substances per manufacturing batch records and 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 records and logbooks following GDP at the time of execution.

• Utilize and perform maintenance on equipment per applicable SOP.

• Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).

• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.

• Participate and be accountable for workplace organization (5S).

MINIMUM REQUIREMENTS

Manufacturing Associate I:

Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.

Manufacturing Associate II:

Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent.

All Levels:

Basic knowledge of upstream (cell culture or fermentation) 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.

Language Ability

Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records. Ability to write routine reports and correspondence. Ability to speak effectively to groups.

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

MS Office, ERP, EDMS, production equipment software, other

Equipment Use

Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

WORKING CONDITIONS

Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, workspace, etc.)?

Yes

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 hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.