Downstream Manufacturing Associate I/ll

About the role

The Manufacturing Associate I/II is responsible for performing upstream processing for biopharmaceutical products. The role requires adherence to 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). The Manufacturing Associate may 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 role involves upstream unit operations such as seed expansion, bioreactor operations, and 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) and general bioprocessing equipment (filters, filter integrity testers, balances, pumps, pH/conductivity meters, disposable technologies).

Staff will maintain ownership of production processes, the manufacturing environment, and the facility, working cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure successful, reliable, and compliant operations.

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).

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.
• 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.
• Fluent in reading and writing the English language.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, and batch production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively to groups.
• Ability to solve practical problems and deal with variables in situations with limited standardization.
• Ability to interpret instructions furnished in written, oral, diagram, or schedule form.

Skills

• Proficiency in MS Office, ERP, EDMS, production equipment software, and other relevant systems.
• Ability to use upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.
• Basic math skills: addition, subtraction, multiplication, division, computation of rate, ratio, percent, and interpretation of graphs.

Schedule

This position follows a 2-2-3 shift schedule on the Day Shift (7am-7pm), requiring 12-hour shifts which may include overnight work.

Working Conditions

• Work within a cGMP manufacturing biotechnology facility, including cleanroom operations that require donning cleanroom attire and maintaining good personal hygiene.
• Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling hazards.
• Moderate to high noise levels in the work environment.
• Standing, sitting for long periods, and occasional lifting, pushing, pulling, or ladder use may be required.