KBI: US - Downstream Senior Manufacturing Associate II (Night Shift)

KBI Biopharma•Durham, NC

About The Position

The Senior Manufacturing Associate II performs downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The role follows approved procedures and records to ensure right-first-time work in compliance with GMP, good documentation practices, and/or GLP. Responsibilities may include authoring SOPs and Master Batch Records, writing CAPAs, and specifying, commissioning, and qualifying equipment. The associate performs downstream unit operations—including chromatography, tangential flow filtration, viral inactivation, and bulk filling—and/or manufacturing support activities such as solution preparation, assembly preparation, parts washing, and autoclaving. The role requires working knowledge of downstream processing and/or manufacturing support equipment, along with general bioprocessing equipment and disposable technologies. The Senior Manufacturing Associate uses experience to teach, troubleshoot, and continuously improve manufacturing operations. The associate executes tasks with minimal supervision, maintains ownership of production processes and the facility, and communicates effectively with the supervisor and cross-functional support groups. The role also includes reviewing schedules, executed manufacturing documentation, and ERP orders to support compliant operations and schedule adherence, and escalating questions, concerns, or deviations through internal notification processes. This is a night-shift position, 7 p.m.–7 a.m., on a rotating 2-2-3 schedule. Work is performed in a cleanroom and may require prolonged standing or sitting, as well as lifting, pushing, pulling, and ladder use when setting up bioreactors.

Requirements

Bachelor’s degree in a related scientific or engineering discipline and 5+ years of experience in related GMP manufacturing operations; alternatively, a high school degree and 10+ years of experience in related GMP manufacturing operations.
Excellent written and verbal communication skills.
Fluent reading and writing in English; able to interpret safety rules, operating and maintenance instructions, procedure manuals, and batch production records.
Ability to write routine reports and correspondence and speak effectively to groups.
Ability to solve practical problems with limited standardization and interpret written, oral, diagrammatic, or schedule-based instructions.
Ability to perform arithmetic with whole numbers, common fractions, and decimals; compute rates, ratios, and percentages; and draw and interpret graphs.
Ability to work with minimal supervision and communicate effectively with supervisors and support groups.
Ability to stand and sit for extended periods; lift, push, and pull equipment or materials; and use a ladder when setting up bioreactors.
Computer skills with MS Office, ERP, EDMS, production equipment software, and other software.
Energetic, motivated, and dynamic individual.

Nice To Haves

Basic knowledge of upstream unit operations such as cell culture or fermentation, or downstream unit operations such as purification and bulk filling.
Experience with single-use platform technology.
Past experience and working knowledge of downstream processing equipment such as mixing vessels, chromatography systems, tangential flow filters, and virus filters, and/or manufacturing support equipment such as mixing vessels, parts washers, and autoclaves.
Knowledge of general bioprocessing equipment, including filters, filter integrity testers, balances, pumps, pH/conductivity meters, and disposable technologies such as disposable bags, sterile tubing welders, and tubing sealers.

Responsibilities

Manufacture bulk intermediates and drug substances according to manufacturing batch records, quality standards, company policies, and current regulations.
Perform operations in a cleanroom environment, applying aseptic-processing controls, including gowning and cleaning procedures.
Document manufacturing-record and logbook tasks at the time of execution in accordance with good documentation practices.
Use and perform maintenance on equipment according to applicable SOPs.
Ensure materials are issued and accounted for during execution of records, including SR, EPR, and BR.
Demonstrate, apply, and promote understanding of cGMP as it applies to assigned tasks and responsibilities.
Participate in and be accountable for workplace organization (5S).
Provide direction and guidance to Manufacturing Associates.
Assist the supervisor with workload distribution and ensure others understand their task requirements.
Perform downstream unit operations such as chromatography, tangential flow filtration, viral inactivation, and bulk filling, and/or manufacturing support operations such as solution preparation, assembly preparation, parts washing, and autoclaving.
As needed, work individually or on teams to author SOPs or Master Batch Records, write CAPAs, and specify, commission, and qualify new equipment.
Teach, troubleshoot, and continuously improve daily manufacturing operations.
Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments to support successful, reliable, compliant operations.
Review manufacturing schedules, executed documentation, and ERP orders for compliance and schedule adherence.
Communicate questions, concerns, and deviations to management and the quality system through internal notification processes.