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

NCBioImpact; North Carolina; Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II for night shift to perform downstream processing and support manufacturing operations in a GMP-compliant environment.

The role involves working with chromatography, filtration, viral inactivation, and bulk filling under controlled procedures. The position requires a Bachelor’s degree with 5+ years of GMP experience and strong documentation, communication, and problem-solving skills.

Qualifications

• Bachelor’s degree with 5+ years’ GMP manufacturing experience.
• Knowledge of upstream or downstream unit operations preferred.
• Excellent written and verbal communication skills.

Responsabilités

• Manufacture bulk intermediates and drug substances per batch records.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document tasks following GDP and GMP protocols.
• Operate and maintain equipment per SOPs.
• Ensure materials are issued and accounted for during records.
• Apply cGMP concepts to tasks and responsibilities.
• Support workplace organization (5S) and cross-functional communication.
• Provide guidance to Manufacturing Associates and assist supervisor with workload.

Connaissances

GMP knowledge

GLP knowledge

SOP writing

CAPA writing

Team collaboration

Formation

Bachelor’s degree in science/engineering

Outils

ERP systems

EDMS

Production software

Description du poste

JOB SUMMARY

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

The Senior Manufacturing Associate II - Nights (Sr. Manufacturing Associate) is responsible for performing 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 Sr. Manufacturing Associate will be responsible for 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) activities. The Sr. Manufacturing Associate will have past experience and a working knowledge of downstream processing equipment (mixing vessels, chromatography, tangential flow filters, virus filters), and/or manufacturing support equipment (mixing vessels, parts washers, and autoclaves). Additionally, the manufacturing associate will have 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).

The Sr. Manufacturing Associate will use past experiences and knowledge to teach, troubleshoot and continuously improve the daily operations of upstream or downstream manufacturing. Staff will maintain a sense of ownership of the production processes, the manufacturing environment, and the facility. The Sr. Manufacturing Associate will execute daily tasks and maintain strict accordance with manufacturing records, SOPs, and GMP with minimal supervision and effectively communicate with the manufacturing supervisor 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 also be expected to review the manufacturing schedule, executed manufacturing documentation, and ERP orders to ensure compliant operations and schedule adherence. Staff will effectively communicate questions, concerns, or deviations to management and the quality system according to KBI internal notification processes.

JOB 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.

MINIMUM REQUIREMENTS

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.

Language Ability

Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records. Ability to write routine reports and correspondence. Ability to speak effectively to groups.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

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.

Physical Demands

Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors.

Computer Skills

MS Office, ERP, EDMS, production equipment software, other

Equipment Use

Downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.