Job Description

Position Summary:

The incumbent will lead manufacturing planning to ensure ‘Right the First time’ execution of early and late-phase Cell Culture programs safeguarding work environments and enforcing cGMP compliant operations. Production scope Upstream or Downstream processing.

Supervisors will assign and supervise daily tasks of team members and maintain strict accordance with production batch records, SOPs and Good Manufacturing Practices. This proven and qualified candidate will use their past experiences, depth and knowledge of cell culture fundamentals in media preparation, seed expansion, bioreactor operations, cell culture harvest operations, chromatography, ultrafiltration, and drug substance filling operations to teach, troubleshoot and continuously improve the daily operations of Manufacturing. The ideal candidate will be both technically sound as well as an experienced team motivator and coach.

Demonstrated knowledge of media preparation, shake flask operations, reactor setup and operation, aseptic technique, cell culture media preparation, chromatography, ultrafiltration, and drug substance filling operations, analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity meters) is expected as the supervisor will teach, promote and enforce precise and compliant operations.

The supervisor will review and understand manufacturing procedures and apply their fundamental knowledge combined with production batch records to train manufacturing personnel ensuring manufacturing operations are conducted accurately, safely and compliantly. The supervisor will maintain a sense of ownership of the production processes, manufacturing environment and facility. Following task execution, the supervisor will review the executed production batch records, and ERP orders 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:

• Plan, schedule, and support daily production tasks to ensure schedule adherence while maintaining a successful and GMP compliant execution. Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
• Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders.
• Ensure timely corrections to batch documentation and logbooks.
• Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees.
• Ensure staff maintain a high level of compliance to procedures and quality expectations.
• Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
• Author, train, review manufacturing procedures

Requirements:

Education and Knowledge:

• Supervisor: Bachelor’s degree in a related scientific or engineering discipline and 4-8 years’ experience in related GMP manufacturing operations; or 10-15 years’ experience with a high school degree, or equivalent.
• Demonstrated knowledge of cell culture, fermentation or purification unit operation is preferred. Experience in single-use platform technology is preferred.
• Prior experience in a lead/leadership role is preferred.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual. Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Language Skills:

• Fluent in English Language both reading and writing.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of organization.

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

• Combination of sitting, standing and walking within the Manufacturing classified spaces and administrative areas.
• Must able to effectively don required gowning within Manufacturing areas.

Computer Skills and Equpment Experience:

• Knowledge of and previous experience using MS Office, ERP, EDMS, production equipment software, other Equipment Use Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Peristaltic Pumps and Other Single Use pumps, Automated Cell Counters, Blood Gas Analyzers, Metabolite Analyzers, Scales and Balances, pH and Osmolality meters, Other lab equipment, other production equipment, and Office equipment.

Range: $100,000.00r. - $138,600.00 / yr.

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.