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 forms to ensure work is conducted right first time and in accordance with GMP, good documentation practices, and/or GLP. With minimal supervision, the associate performs daily tasks, maintains compliance with manufacturing records and SOPs, and communicates effectively with the manufacturing supervisor and support groups. Responsibilities may include downstream unit operations such as chromatography, tangential flow filtration, viral inactivation, and bulk filling, as well as manufacturing support operations such as solution preparation, assembly preparation, parts washing, and autoclaving. The role requires working knowledge of relevant processing and support equipment and general bioprocessing equipment. The associate may help author SOPs or Master Batch Records, write CAPAs, and specify, commission, or qualify new equipment. The associate uses experience to teach, troubleshoot, and improve manufacturing operations; maintains ownership of production processes, the manufacturing environment, and the facility; and works cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments. The position also reviews schedules, executed manufacturing documentation, and ERP orders to support compliant operations and schedule adherence, and escalates questions, concerns, or deviations through internal notification processes. The stated night schedule is 7 p.m.–7 a.m. on a rotating 2-2-3 schedule.

Requirements

Bachelor’s degree in a related scientific or engineering discipline and at least 5 years of experience in related GMP manufacturing operations; alternatively, a high school degree and at least 10 years of experience in related GMP manufacturing operations.
Fluent in reading and writing English; able to read and interpret safety rules, operating and maintenance instructions, procedure manuals, and batch production records.
Able to write routine reports and correspondence and speak effectively to groups.
Able to solve practical problems and handle concrete variables where standardization is limited.
Able to interpret written, oral, diagrammed, or scheduled instructions.
Able to perform arithmetic with whole numbers, fractions, and decimals; compute rates, ratios, and percentages; and draw and interpret graphs.
Excellent written and verbal communication skills.
Energetic, motivated, and dynamic.
Able to meet the physical demands described, including prolonged standing or sitting, lifting, pushing, pulling, and ladder use when setting up bioreactors.
Computer skills with MS Office, ERP, EDMS, production equipment software, and other relevant systems.

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, including mixing vessels, chromatography systems, tangential flow filters, and virus filters, and/or manufacturing support equipment, including 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, applying controls for aseptic processing, including gowning and cleaning procedures.
Document manufacturing tasks in records and logbooks in accordance with good documentation practices at the time of execution.
Use and perform maintenance on equipment according to applicable SOPs.
Ensure materials are issued and accounted for during execution of a record, including SR, EPR, and BR.
Demonstrate and apply cGMP knowledge and ensure understanding of how it applies to assigned tasks and responsibilities.
Participate in and be accountable for workplace organization (5S).
Provide direction and guidance to Manufacturing Associates; help the supervisor distribute workload and ensure others understand task requirements.
Perform downstream processing and/or manufacturing support operations, including applicable unit operations and equipment activities.
Help author SOPs or Master Batch Records, write CAPAs, and specify, commission, and qualify new equipment as needed.
Teach, troubleshoot, and continuously improve manufacturing operations.
Review manufacturing schedules, executed documentation, and ERP orders to support compliance and schedule adherence.
Communicate questions, concerns, and deviations to management and through internal quality-system notification processes.
Work cross-functionally with QA, MS&T, facilities, engineering, supply chain, IT, AFS, and other departments.