Manufacturing Associate II (Biopharma)

Location: USA - NC - Durham - National Way; onsite 2-2-3 schedule with 12-hour day shifts from 6am to 6pm

Company

Biopharmaceutical manufacturing organization producing bulk intermediates and drug substances.

What you will do

• Manufacture bulk intermediates and drug substances according to batch records, SOPs, GMP, and current regulations.
• Perform upstream, downstream, and manufacturing-support operations, including cell culture, bioreactors, chromatography, filtration, bulk filling, solution preparation, parts washing, and autoclaving.
• Execute aseptic processing in cleanrooms, including gowning and cleaning procedures.
• Document production activities and review manufacturing records and logbooks for GxP compliance.
• Operate and maintain bioprocessing, production, and in-process testing equipment.
• Collaborate with QA, MS&T, facilities, engineering, supply chain, IT, and other departments to support reliable manufacturing operations.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline with 2–5 years of related cGMP manufacturing experience, or a high school degree with 4–6 years of experience, or equivalent.
• Working knowledge of upstream, downstream, or manufacturing-support unit operations.
• Fluent English reading and writing skills are required, including the ability to interpret procedures, safety rules, maintenance instructions, and batch records.
• Ability to solve practical problems, interpret varied instructions, and perform basic calculations involving rates, ratios, percentages, fractions, and decimals.
• Ability to work 12-hour shifts, including potential overnight shifts, in a cleanroom and cGMP biotechnology manufacturing facility.
• Ability to stand and sit for extended periods and lift, push, pull, or use ladders when required.

Culture & Benefits

• Work in a fast-paced, multi-tasked manufacturing environment requiring organization, attention to detail, accountability, and operational efficiency.
• Use MS Office, ERP, EDMS, production equipment software, and in-process testing instruments.
• Participate in workplace organization through 5S practices.
• Operate in an environment with mechanical, chemical, electrical, noise, and trip-and-fall hazards.