Job Description

Please Note: This is a night shift opportunity and is eligible for a shift differential on top of the posted range

Position Summary

This position is on a 2-2-3 shift, with the hours 6p-6a. The Sr. 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 Sr. 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). Identify possible process and record improvements and communicate findings to the appropriate personnel.

The ideal candidate will be both technically sound and have a quality mindset. The candidate will use and demonstrate their past experiences and knowledge of purification fundamentals in cell culture clarification, chromatography operations, viral inactivation, ultrafiltration/diafiltration, various other filtration techniques utilizing single use technologies, as well as their use of various analytical tools (SoloVPE, pH/Conductivity meters) and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, scales) to teach, troubleshoot and continuously improve the daily operations of Downstream manufacturing. The Sr. Manufacturing Associate I/II – Downstream will promote and enforce precise and compliant operations.

The Sr. Manufacturing Associate I/II will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the Sr. Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that any deviations/events are documented and escalated to the Management and Quality system according to KBI internal notification processes.

Position Responsibilities

• Purification of cell culture products per manufacturing batch records and 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.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials/items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.
• Provide direction/guidance to Manufacturing Associate I and Manufacturing Associate II, Senior Manufacturing Associate I and Senior Manufacturing Associate II. Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Minimum Requirements

• Sr. Manufacturing Associate I- Bachelor’s degree in a related scientific or engineering discipline with 2+ years’ experience in related GMP manufacturing operations; or high school diploma with 3+ years’ experience in related GMP manufacturing operations.
• Sr. Manufacturing Associate II- Bachelor’s degree in a related scientific or engineering discipline and 4+ years’ experience in related GMP manufacturing operations; or high school diploma with 5+ years’ experience in related GMP manufacturing operations.
• Demonstrated knowledge of downstream or purification unit operations.
• Must have demonstrated leadership skills.
• 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 Requirements

• Biowork certification.
• Experience in single-use platform technology.
• Experience in CDMO.

Salary range:

Senior MA I: $30/hr. - $41.25/hr.

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.

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.