KBI: US - Manufacturing Associate I

KBI Biopharma; Durham (NC); On-site; USD 52,000 - 72,000; Full time

Job summary

KBI Biopharma in Durham (NC) is seeking a Manufacturing Associate I/II - Downstream to execute purification and cell culture support in a GMP environment.

You will perform chromatography, viral inactivation, ultrafiltration, document records with GDP/GMP, and uphold Right the First Time. Shift is a 2-2-3 schedule (6am-6pm) with cleanroom duties and 12-hour shifts including weekends.

Qualifications

• High school diploma required.
• Experience in a regulated industry or knowledge of downstream/purification unit operations.
• Ability to follow written instructions.
• Excellent written and verbal communication skills.
• Detail-oriented, organized, and able to work in a fast-paced environment.
• Willingness to work a 12-hour schedule including weekends, nights and holidays.

Responsibilities

• Purify cell culture products per batch records using chromatography, filtration, and viral reduction techniques.
• Perform operations in a cleanroom environment with aseptic processing controls.
• Document tasks in SRs, EPRs, and BRs following GDP.
• Ensure materials are issued and accounted for during execution.
• Demonstrate understanding of cGMP and its application to tasks.
• Support 5S in the room and equipment maintenance per SOPs.

Skills

Communication skills

Attention to detail

Organization

Multi-tasking

Education

High school diploma

Job description

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

This position is on a 2-2-3 shift, 6a-6p. The Manufacturing Associate I/II - Downstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II - Downstream must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including 'Right the First Time' (RFT). Downstream is responsible for the execution of purification activities for early and late-phase Cell Culture programs within a GMP environment. The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to cell culture clarification, chromatography operations using the Cytiva UNICORN software application, viral inactivation, ultrafiltration/diafiltration systems, various other filtration techniques utilizing single use technologies. Various analytical tools (SoloVPE, pH/Conductivity meters) and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, scales) are used on a daily basis. Following task execution, the Manufacturing Associate I/II will review the executed production records (SR's, EPR, and BR's) to ensure GxP compliance.

Position Responsibilities:

• Purification of cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, purification processing using various chromatography, filtration, and viral reduction techniques up through bulk fill of drug product/intermediate.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution.
• Ensure all materials/items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR)
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.
• Utilize and perform maintenance on equipment per applicable SOP's.

Requirements:

• High school diploma.
• Experience in a regulated industry or demonstrated knowledge of downstream or purification unit operations.
• Ability to follow written instructions.
• Excellent written and verbal communication skills.
• Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
• Energetic, motivated and dynamic individual.
• Must have high attention to detail.
• Ability to work a 12-hour schedule to include weekends, nights and Holidays.

Preferred Qualifications:

• Associates or Bachelor's degree in a related scientific or engineering discipline
• Biowork certification.
• Experience in single-use platform technology.
• Experience in a CDMO.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.