Sop Writer Jobs in Raleigh, NC (NOW HIRING)

Position Summary

This position is on a 2-2-3 shift, 6p-6a. 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 responsi

ble 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, ERP, 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.

Position 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.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.