KBI Biopharma Inc.
Manufacturing Sciences Engineer II
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
JOB SUMMARY
The Upstream MS&T Engineer II will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes: Leading technical transfer projects for platform and/or repeat clinical manufacturing programs Supporting and/or driving business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client Performing facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing Compiling, collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports JOB RESPONSIBILITIES
The candidate should be able to apply engineering principles in-order to problemsolve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams. The candidate should also possess excellent communication skills. Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection. 40% Author / Review technical documents including supporting batch records, solution/media records, project reports, manufacturing process calculations templates, user requirements specifications, etc. 10% Lead technical deviation investigations and collaborate with Manufacturing, Investigators and QA to determine event impact, perform root-cause analysis and corrective action identification and implementation. 10% Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications. 10% Author and revise Material Specifications in accordance with compendia requirements and meeting grade requirements for introduced process. 5% Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor. 10% Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings. 10% Escort client into manufacturing suites for Person in Plant activities 5% Minimum Requirements
BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience. Expertise in upstream and/or downstream processing techniques and equipment in biologics. Experience with technical transfer and scale up is required. Experience with GMP compliance requirements. Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production. Experience working in a cGMP manufacturing environment is preferred. Language Ability
Strong proficiency in English and overall communication is required. Reasoning Ability
Strong engineering and scientific reasoning skills are required. Math Ability
Strong Math Skills are required. Physical Demands
Position requires limited physical demands. Computer Skills
Strong computers skills are required particularly in all MS Office programs. Equipment Use
Some equipment operations and testing is required. EEO Statement
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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. Vaccination Requirement
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.
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The Upstream MS&T Engineer II will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes: Leading technical transfer projects for platform and/or repeat clinical manufacturing programs Supporting and/or driving business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client Performing facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing Compiling, collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports JOB RESPONSIBILITIES
The candidate should be able to apply engineering principles in-order to problemsolve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams. The candidate should also possess excellent communication skills. Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection. 40% Author / Review technical documents including supporting batch records, solution/media records, project reports, manufacturing process calculations templates, user requirements specifications, etc. 10% Lead technical deviation investigations and collaborate with Manufacturing, Investigators and QA to determine event impact, perform root-cause analysis and corrective action identification and implementation. 10% Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications. 10% Author and revise Material Specifications in accordance with compendia requirements and meeting grade requirements for introduced process. 5% Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor. 10% Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings. 10% Escort client into manufacturing suites for Person in Plant activities 5% Minimum Requirements
BS in Science or Engineering with minimum of 4 years industry experience, Master’s with 2 years industry experience or PhD with no years industry experience. Expertise in upstream and/or downstream processing techniques and equipment in biologics. Experience with technical transfer and scale up is required. Experience with GMP compliance requirements. Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production. Experience working in a cGMP manufacturing environment is preferred. Language Ability
Strong proficiency in English and overall communication is required. Reasoning Ability
Strong engineering and scientific reasoning skills are required. Math Ability
Strong Math Skills are required. Physical Demands
Position requires limited physical demands. Computer Skills
Strong computers skills are required particularly in all MS Office programs. Equipment Use
Some equipment operations and testing is required. EEO Statement
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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. Vaccination Requirement
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.
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