KBI: US - Senior Manufacturing Associate II

KBI Biopharma; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II to perform upstream or downstream bioprocessing for biopharmaceutical products.

The role requires adherence to GMP, GDP, and GLP, and may involve authoring SOPs/MBRs, CAPAs, and equipment qualification. 12-hour shifts (6PM-6AM) on a rotating 2-2-3 schedule in a cGMP facility with cross-functional collaboration across QA, MS&T, facilities, and IT.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 4–6 years' GMP manufacturing experience or high school with 7–10 years' GMP manufacturing experience.
• Bachelor's degree with 5+ years' GMP manufacturing experience for Senior Manufacturing Associate II; high school with 10+ years' experience for Senior Manufacturing Associate II.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and in compliance with quality standards.
• Perform aseptic operations in a cleanroom environment including gowning and cleaning procedures.
• Document tasks in manufacturing records and logbooks per GDP at execution.
• Maintain equipment per applicable SOP and ensure materials are issued and accounted for.
• Demonstrate understanding of cGMP and apply it to tasks and responsibilities.
• Support workplace organization and cross-functional collaboration with QA, MS&T, facilities, engineering, supply chain, IT, and other groups.

Education

Bachelor's degree in a related scientific or engineering discipline

High school degree with related GMP manufacturing operations experience

Excellent written and verbal communication skills

Job description

• Nightshift: 6PM-6AM, 2-2-3 rotating schedule

The Senior Manufacturing Associate I/II (Days) is responsible for performing upstream or 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 upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), 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 upstream processing equipment (incubators, biosafety cabinets, bioreactors, cell counters, blood gas analyzers, metabolite testing equipment), 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

Senior Manufacturing Associate I

• Bachelor's degree in a related scientific or engineering discipline with 4-6 years' experience in related GMP manufacturing operations; or high school degree with 7-10 years' experience in related GMP manufacturing operations.

Senior Manufacturing Associate II

• 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

Upstream or downstream bioprocessing equipment, general production equipment, in-process testing instruments, and office equipment.

WORKING CONDITIONS

The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.

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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.