KBI Biopharma Inc.
KBI: US - Senior Manufacturing Associate I (Nights)
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
KBI: US - Senior Manufacturing Associate I (Nights) page is loaded## KBI: US - Senior Manufacturing Associate I (Nights)locations:
USA - NC - Durham - Hamlin Rdtime type:
Full timeposted on:
Posted 3 Days Agojob requisition id:
R00008063·
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 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 I/II 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.·
2. JOB RESPONSIBILITIES Responsibility Approximate % of Time Sr. MA I Sr. MA II Manufacture cell culture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations. 25% 20% Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. 15% 15% Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution. 15% 15% Utilize and perform maintenance on equipment per applicable SOP. 10% 10% Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR). 10% 10% Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities. 10% 10% Participate and be accountable for room 5S. 10% 10% 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. 5% 10% Total: 100% 3. MINIMUM REQUIREMENTS 3.1 Knowledge, Skills, Abilities Level Minimum Requirement Sr. Manufacturing Associate I 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. Sr. Manufacturing Associate II Bachelor’s degree in a related scientific or engineering discipline and 5+ years’ experience in related GMP manufacturing operations; or high school diploma with 10+ years’ experience in related GMP manufacturing operations. · 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·
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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. Essential Physical Functions Check physical demands that apply. Describe job responsibilities that require physical demands checked. 1. Strength a. Standing 50 % of time Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Walking 25 % of time Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Sitting 25 % of time Staff will perform activities such as training, document review, and other computer work, as required. b. Lifting 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Carrying 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Pushing 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. Pulling 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. 2. Climbing Staff must perform some operations on ladders or step stools. Balancing Staff must perform some operations on ladders or step stools. 3. Stooping Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Kneeling Crouching Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Crawling 4. Reaching Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use. Handling 5. Speaking Staff must be fluent in English language. Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise. Staff will read production instructions to others and appropriately understand instructions. Hearing Staff must be fluent in English language. Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise. Staff will listen to other staff during reading of production instructions and appropriately understand instructions.·
Seeing Staff must be able to read manufacturing procedures and execute production activities. Depth Perception Color Vision Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time*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 #J-18808-Ljbffr
USA - NC - Durham - Hamlin Rdtime type:
Full timeposted on:
Posted 3 Days Agojob requisition id:
R00008063·
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 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 I/II 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.·
2. JOB RESPONSIBILITIES Responsibility Approximate % of Time Sr. MA I Sr. MA II Manufacture cell culture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations. 25% 20% Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. 15% 15% Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution. 15% 15% Utilize and perform maintenance on equipment per applicable SOP. 10% 10% Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR). 10% 10% Demonstrate, apply and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities. 10% 10% Participate and be accountable for room 5S. 10% 10% 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. 5% 10% Total: 100% 3. MINIMUM REQUIREMENTS 3.1 Knowledge, Skills, Abilities Level Minimum Requirement Sr. Manufacturing Associate I 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. Sr. Manufacturing Associate II Bachelor’s degree in a related scientific or engineering discipline and 5+ years’ experience in related GMP manufacturing operations; or high school diploma with 10+ years’ experience in related GMP manufacturing operations. · 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·
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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. Essential Physical Functions Check physical demands that apply. Describe job responsibilities that require physical demands checked. 1. Strength a. Standing 50 % of time Staff will stand throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Walking 25 % of time Staff will walk throughout facility to various locations during production activities and within production rooms in order to accomplish production tasks. Sitting 25 % of time Staff will perform activities such as training, document review, and other computer work, as required. b. Lifting 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Carrying 50 lbs. Staff will lift and carry 20kg bags of WFI, Buffer and Media within facility, as needed. Pushing 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. Pulling 450 lbs. Staff will push 200kg drums of WFI, Buffer, and Media throughout facility, as needed. 2. Climbing Staff must perform some operations on ladders or step stools. Balancing Staff must perform some operations on ladders or step stools. 3. Stooping Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Kneeling Crouching Staff must be able to reach underneath production equipment for bioprocess container installation and inspection. Crawling 4. Reaching Staff must be able to reach underneath, over, and within production equipment for bioprocess container installation, inspection and use. Handling 5. Speaking Staff must be fluent in English language. Staff must be able to speak with other staff over radios, cell phones, and within production locations over machine noise. Staff will read production instructions to others and appropriately understand instructions. Hearing Staff must be fluent in English language. Staff must be able to hear other staff over radios, cell phones, and within production locations over machine noise. Staff will listen to other staff during reading of production instructions and appropriately understand instructions.·
Seeing Staff must be able to read manufacturing procedures and execute production activities. Depth Perception Color Vision Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time*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 #J-18808-Ljbffr