Senior Manufacturing Associate I/II (Nights) - Downstream

Nightshift: 7PM-7AM, 2-2-3 rotating schedule

About the Role

The Senior Manufacturing Associate I/II (Nights) performs upstream or downstream processing of bulk intermediates and/or bulk drug substances 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 Sr. 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.

Responsibilities include upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling), and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave).

The role requires experience with upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). 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) is also required.

The Sr. Manufacturing Associate will use past experience to teach, troubleshoot, and continuously improve daily operations. The role involves maintaining ownership of production processes, the manufacturing environment, and the facility, while working cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other key departments to ensure compliant and reliable 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).
• Provide direction/guidance to Manufacturing Associates and help supervisors distribute workloads.
• Review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence.
• Communicate questions, concerns, or deviations to management and the quality system according to internal notification processes.

Requirements

Sr. Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ experience in related GMP manufacturing operations; or high school degree with 7-10 years’ experience in related GMP manufacturing operations.

Sr. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ experience in related GMP manufacturing operations; or high school degree with 10+ years’ experience in related GMP manufacturing operations.

• Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) unit operations is preferred.
• Experience in single-use platform technology is preferred.
• Excellent written and verbal communication skills are required.
• Must be energetic, motivated, and dynamic.

Skills

• Language Ability: Fluent in reading and writing English. 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.
• Reasoning Ability: Ability to solve practical problems and deal with variables in situations with limited standardization. Ability to interpret instructions 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.
• Computer Skills: Proficiency in MS Office, ERP, EDMS, production equipment software, and other relevant systems.

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.

Equipment Use

• Upstream or downstream bioprocessing equipment (e.g., incubators, bioreactors, chromatography systems).
• General production equipment (e.g., mixing vessels, parts washers, autoclaves).
• In-process testing instruments (e.g., pH/conductivity meters, balances).
• Office equipment.

Working Conditions

• 12-hour shifts, including overnight work.
• Work within a cGMP manufacturing biotechnology facility, including cleanroom operations requiring cleanroom attire and good personal hygiene.
• Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling hazards.
• Moderate to high noise levels in the environment.