NCBiotech
KBI: US - Senior Manufacturing Associate I (Nights)
NCBiotech, Durham, North Carolina, United States, 27703
Overview
JOB SUMMARY: The Sr. Manufacturing Associate I/II 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 SRs, EPRs, BRs, SOPs and forms. All work should be conducted following GMP, GDP and GLP guidelines, including Right the First Time (RFT). Identify possible process and record improvements and communicate them to the appropriate personnel. The candidate will apply knowledge of cell culture Upstream or Downstream fundamentals (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) and related analytical tools and equipment to teach, troubleshoot and continuously improve daily manufacturing operations. The Sr. Manufacturing Associate I/II will promote and enforce precise and compliant operations, maintain ownership of production processes, the manufacturing environment and facility, and review executed production records (SRs, ERP, BRs) to ensure complete and accurate actions. Deviations/events should be documented and escalated per internal notification processes. Responsibilities
Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. (Sr. MA I: 25%, Sr. MA II: 20%) Perform operations in a cleanroom environment with aseptic processing controls including gowning and cleaning procedures. (15% each) Document each task involving manufacturing procedures (SRs, EPRs and BRs) following GDP at the time of execution. (15% each) Utilize and perform maintenance on equipment per applicable SOP. (10% each) Ensure all items are issued and accounted for during execution of records (SR, EPR, BR). (10% each) Demonstrate and ensure understanding of current Good Manufacturing Practices as they apply to tasks and responsibilities. (10% each) Participate in and be accountable for room 5S. (10% each) Provide direction to Manufacturing Associate I/II and Senior Manufacturing Associates; assist supervisor in workload distribution and task clarity. (Sr. MA I/II: 5%/10%) Minimum Requirements
3.1 Knowledge, Skills, Abilities Sr. Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ GMP manufacturing experience; or high school diploma with 7–10 years’ GMP manufacturing experience. Sr. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ GMP manufacturing experience; or high school diploma with 10+ years’ GMP manufacturing experience. Demonstrated knowledge of cell culture, fermentation or purification unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. 3.2 Language Ability: Fluent in English (reading and writing). Ability to read and interpret 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. 3.3 Reasoning Ability: Ability to solve practical problems and interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 3.4 Math Ability: Ability to perform basic arithmetic operations and interpret graphs as needed. 3.5 Physical Demands: Standing and sitting for long periods; lifting/pushing/pulling equipment; possible ladder use for bioreactor setup. 3.6 Computer Skills: MS Office, ERP, EDMS, production equipment software, other. 3.7 Equipment Use: Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Pumps, Automated Cell Counters, Analyzers, Scales, Balances, pH and Osmolality meters, and other related equipment. Working Conditions
The job requires 12-hour shifts which may include overnight work in a cGMP manufacturing biotechnology facility with clean room operations. Donning clean room attire and maintaining good personal hygiene in clean room areas. Exposure to mechanical, chemical, electrical hazards; potential noise level is moderate to high. The following physical requirements may apply: ability to stand 50% of the time, walk 25%, sit 25%; lift up to 50 lbs (20 kg), push/pull heavy loads, climb ladders, reach and handle equipment; fluency in English for communication; ability to read procedures and execute production activities. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants are encouraged to apply. I understand that employment is not guaranteed by submitting an application and that either KBI Biopharma, Inc. or the applicant can terminate employment at any time and for any reason, with or without cause and without prior notice. No representative has the authority to make any contrary assurance. I attest that I have provided true and complete information and authorize reference checks. Providing false information may result in denial of employment or immediate dismissal.
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JOB SUMMARY: The Sr. Manufacturing Associate I/II 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 SRs, EPRs, BRs, SOPs and forms. All work should be conducted following GMP, GDP and GLP guidelines, including Right the First Time (RFT). Identify possible process and record improvements and communicate them to the appropriate personnel. The candidate will apply knowledge of cell culture Upstream or Downstream fundamentals (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) and related analytical tools and equipment to teach, troubleshoot and continuously improve daily manufacturing operations. The Sr. Manufacturing Associate I/II will promote and enforce precise and compliant operations, maintain ownership of production processes, the manufacturing environment and facility, and review executed production records (SRs, ERP, BRs) to ensure complete and accurate actions. Deviations/events should be documented and escalated per internal notification processes. Responsibilities
Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. (Sr. MA I: 25%, Sr. MA II: 20%) Perform operations in a cleanroom environment with aseptic processing controls including gowning and cleaning procedures. (15% each) Document each task involving manufacturing procedures (SRs, EPRs and BRs) following GDP at the time of execution. (15% each) Utilize and perform maintenance on equipment per applicable SOP. (10% each) Ensure all items are issued and accounted for during execution of records (SR, EPR, BR). (10% each) Demonstrate and ensure understanding of current Good Manufacturing Practices as they apply to tasks and responsibilities. (10% each) Participate in and be accountable for room 5S. (10% each) Provide direction to Manufacturing Associate I/II and Senior Manufacturing Associates; assist supervisor in workload distribution and task clarity. (Sr. MA I/II: 5%/10%) Minimum Requirements
3.1 Knowledge, Skills, Abilities Sr. Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline with 4–6 years’ GMP manufacturing experience; or high school diploma with 7–10 years’ GMP manufacturing experience. Sr. Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 5+ years’ GMP manufacturing experience; or high school diploma with 10+ years’ GMP manufacturing experience. Demonstrated knowledge of cell culture, fermentation or purification unit operation is preferred. Experience in single-use platform technology is preferred. Excellent written and verbal communication skills are required. 3.2 Language Ability: Fluent in English (reading and writing). Ability to read and interpret 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. 3.3 Reasoning Ability: Ability to solve practical problems and interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 3.4 Math Ability: Ability to perform basic arithmetic operations and interpret graphs as needed. 3.5 Physical Demands: Standing and sitting for long periods; lifting/pushing/pulling equipment; possible ladder use for bioreactor setup. 3.6 Computer Skills: MS Office, ERP, EDMS, production equipment software, other. 3.7 Equipment Use: Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids, Filling systems, Pumps, Automated Cell Counters, Analyzers, Scales, Balances, pH and Osmolality meters, and other related equipment. Working Conditions
The job requires 12-hour shifts which may include overnight work in a cGMP manufacturing biotechnology facility with clean room operations. Donning clean room attire and maintaining good personal hygiene in clean room areas. Exposure to mechanical, chemical, electrical hazards; potential noise level is moderate to high. The following physical requirements may apply: ability to stand 50% of the time, walk 25%, sit 25%; lift up to 50 lbs (20 kg), push/pull heavy loads, climb ladders, reach and handle equipment; fluency in English for communication; ability to read procedures and execute production activities. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. All qualified applicants are encouraged to apply. I understand that employment is not guaranteed by submitting an application and that either KBI Biopharma, Inc. or the applicant can terminate employment at any time and for any reason, with or without cause and without prior notice. No representative has the authority to make any contrary assurance. I attest that I have provided true and complete information and authorize reference checks. Providing false information may result in denial of employment or immediate dismissal.
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