Manufacturing Associate II (Nights)

Job Summary

*Nightshift 7PM-7AM 2-2-3 rotating schedule

The Manufacturing Associate II (Nights) is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II must follow the instructions depicted in SRs EPRs BRs SOPs 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). The candidate will maintain a sense of ownership of the production processes manufacturing environment and facility. They will be exposed to various unit operations including media/buffer 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 to analytical tools and general biotechnology auxiliary equipment (pumps sterile tubing welders and sealers pH/Conductivity/osmolality meters). Following task execution the Manufacturing Associate I/II will review the executed production records (SRs ERP and BRs) to ensure GxP compliance.

Job Responsibilities

• Manufacture cell culture products per manufacturing batch records 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 procedures (i.e. SRs EPRs and BRs) following GDP at the time of execution.

• Ensure all 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.

Minimum Requirements

• Bachelors degree in a related scientific or engineering discipline with 2-5 years experience in related GMP manufacturing operations; or high school diploma with 4-6 years experience in related GMP manufacturing operations.

• Basic knowledge of cell culture fermentation or purification unit operations is preferred. Experience in single-use platform technology 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 Ability

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 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

Standing and sitting for long periods of time may be required at times. Lifting pushing and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors.

Computer Skills

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 production and office equipment.

WORKING CONDITIONS

The job requires working 12-hour shifts which may include working overnight. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards chemical hazards electricity hazards and tripping and falling hazards. The noise level in the environment is moderate to high.

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.