Kbi: US - Senior Manufacturing Associate I

Position Summary:

The Sr. Manufacturing Associate is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Sr. Manufacturing Associate I/II 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 this 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 cell culture Upstream or Downstream fundamentals in cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as in analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) to teach, troubleshoot and continuously improve the daily operations of manufacturing. The Sr. Manufacturing Associate will promote and enforce precise and compliant operations.

The Sr. Manufacturing Associate 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

• 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
• 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.

Position Requirements

• Bachelor's degree in a related scientific or engineering discipline with 4-6 years' experience in related GMP manufacturing operations; or high school diploma with 7-10 years' experience in related GMP manufacturing operations
• Knowledge of upstream unite operations preferred
• Experience in single-use technology preferred
• Excellent written and verbal communication skills are required

Salary: $33.65-40.87/hour

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, 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.