Senior Manufacturing Associate I/II - Purification (Nights, 7pm-7am)

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

About the Role

The Senior Manufacturing Associate I/II (Nights) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Sr. 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 Sr. 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 role involves 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 Sr. Manufacturing Associate will use past experience and knowledge to teach, troubleshoot, and continuously improve daily operations. The role requires maintaining ownership of production processes, the manufacturing environment, and the facility, while executing tasks with minimal supervision and collaborating effectively with supervisors and support groups.

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. The Sr. Manufacturing Associate will review the manufacturing schedule, executed documentation, and ERP orders to ensure compliance and schedule adherence, and communicate questions, concerns, or deviations to management and the quality system.

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. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

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.
• Energetic, motivated, and dynamic individual.
• 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.

Skills

• Ability to solve practical problems and deal with concrete variables in situations with limited standardization.
• Ability to interpret instructions furnished in written, oral, diagram, or schedule form.
• 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.
• Proficiency with MS Office, ERP, EDMS, production equipment software, and other relevant systems.
• Working knowledge of 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, 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).

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.
• The use of a ladder may be required when setting up bioreactors.

Working Conditions

• 12-hour shifts which may include working overnight.
• Work within a cGMP manufacturing biotechnology facility requiring cleanroom operations, including donning cleanroom attire and maintaining good personal hygiene.
• Exposure to mechanical hazards, chemical hazards, electricity hazards, and tripping/falling hazards.
• Moderate to high noise levels in the environment.