Senior Manufacturing Associate ll

KBI Biopharma•Durham, NC

3d•Onsite

About The Position

The Manufacturing Associate performs upstream processing for biopharmaceutical products in a cGMP manufacturing facility. The role follows approved procedures and forms to ensure work is completed right first time and in accordance with GMP, good documentation practices, and, where applicable, GLP. Responsibilities include upstream unit operations such as seed expansion, bioreactor operations, and cell culture harvest. The associate uses upstream and general bioprocessing equipment and reviews production records and logbooks for GxP compliance. As needed, the associate may contribute to authoring SOPs or MBRs, writing CAPAs, and specifying, commissioning, and qualifying new equipment. The associate executes daily manufacturing tasks in accordance with manufacturing records, SOPs, and GMP, and maintains ownership of production processes, the manufacturing environment, and the facility. The role works cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments to support successful, reliable, and compliant manufacturing operations. The position requires 12-hour shifts, which may include overnight work, and cleanroom operations requiring cleanroom attire and good personal hygiene.

Requirements

For Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline and 2–5 years of experience in related cGMP manufacturing operations; or a high school degree and 4–6 years of experience, or equivalent.
Excellent written and verbal communication skills.
Fluent in reading and writing English; able to interpret safety rules, operating and maintenance instructions, procedure manuals, and batch production records; write routine reports and correspondence; and speak effectively to groups.
Able to solve practical problems with limited standardization and interpret written, oral, diagram, or schedule-based instructions.
Able to perform basic arithmetic and calculate rates, ratios, and percentages, and draw and interpret graphs.
Able to stand and sit for extended periods; lift, push, and pull items for stocking and moving equipment; and use a ladder when setting up bioreactors.
Computer skills with MS Office, ERP, EDMS, production equipment software, and other software.

Nice To Haves

Basic knowledge of upstream unit operations, such as cell culture or fermentation.
Experience with single-use platform technology.

Responsibilities

Manufacture bulk intermediates and drug substances according to manufacturing batch records, quality standards, company policies, and current regulations.
Perform operations in a cleanroom, applying controls for aseptic processing, including gowning and cleaning procedures.
Document manufacturing tasks in records and logbooks according to GDP at the time of execution.
Use and perform maintenance on equipment according to applicable SOPs.
Ensure materials are issued and accounted for during record execution, including SR, EPR, and BR.
Demonstrate, apply, and ensure understanding of cGMP as it applies to specific tasks and responsibilities.
Participate in and be accountable for workplace organization (5S).
Review executed production records and logbooks to ensure GxP compliance.
Work cross-functionally to support startup and ongoing manufacturing operations.
As needed, contribute to authoring SOPs or MBRs, writing CAPAs, and specifying, commissioning, and qualifying new equipment.