KBI Biopharma
Director, Manufacturing Technical Operations
KBI Biopharma, Durham, North Carolina, United States, 27703
Director, Manufacturing Technical Operations
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Director, Manufacturing Technical Operations
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KBI Biopharma The Director, Manufacturing Technical Operations is responsible for providing technical leadership and oversight of the quality systems for the Manufacturing department. The director leads a team of compliance and technical specialists, reports to the head of manufacturing, and serves on the Manufacturing leadership team. The Director possesses proven technical writing and problem-solving skills and a drive for continuous improvement. The Director has experience using single-use disposable technologies and an understanding of upstream processing, downstream processing, and general biomanufacturing support principles. From a technical perspective, the Director leads a team responsible for system ownership activities such as generating manufacturing procedures and records, procuring and enrolling manufacturing equipment, defining equipment maintenance requirements and spare parts, driving operational excellence initiatives and other activities required of responsible system owners. From a compliance perspective, the Director leads a team that performs thorough and robust manufacturing investigations, implement effective corrective/preventative actions, lead manufacturing compliance and safety walkthroughs, oversee internal and external audits, and manage manufacturing change controls. Responsibilities : Manage, train and mentor a team of Manufacturing Specialists that conduct comprehensive investigations to determine root cause, product impact and implement thorough and effective corrective and preventative actions. Manage, train and mentor a team of Manufacturing Specialists that generates manufacturing procedures and records, procures and enrolls manufacturing equipment, defines equipment maintenance requirements and spare parts, drives operational excellence initiatives, and performs other activities as responsible system owners. Drive process improvement initiatives, troubleshoot issues, track and trend metrics, and author/review/approve technical documents, procedures, deviations, CAPAs, and change controls. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Minimum Requirements Bachelor's degree in a related scientific or engineering discipline with 20+ years biopharmaceutical industry experience and/or training or equivalent 7+ years prior leadership/supervisory experience Demonstrated knowledge of biopharmaceutical manufacturing processes 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 while working in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Fluent in reading and writing the English Language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records. Ability to write routine reports and speak effectively to groups of people. 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. Ability to develop and solve algebraic and exponential math problems by hand or using software. Ability to apply basic statistics to sets of values and develop and interpret different types of graphs. Ability to use computer software - (MS Office, ERP, EDMS, etc) Ability to use production equipment, laboratory equipment, office equipment 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. 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.
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Join to apply for the
Director, Manufacturing Technical Operations
role at
KBI Biopharma The Director, Manufacturing Technical Operations is responsible for providing technical leadership and oversight of the quality systems for the Manufacturing department. The director leads a team of compliance and technical specialists, reports to the head of manufacturing, and serves on the Manufacturing leadership team. The Director possesses proven technical writing and problem-solving skills and a drive for continuous improvement. The Director has experience using single-use disposable technologies and an understanding of upstream processing, downstream processing, and general biomanufacturing support principles. From a technical perspective, the Director leads a team responsible for system ownership activities such as generating manufacturing procedures and records, procuring and enrolling manufacturing equipment, defining equipment maintenance requirements and spare parts, driving operational excellence initiatives and other activities required of responsible system owners. From a compliance perspective, the Director leads a team that performs thorough and robust manufacturing investigations, implement effective corrective/preventative actions, lead manufacturing compliance and safety walkthroughs, oversee internal and external audits, and manage manufacturing change controls. Responsibilities : Manage, train and mentor a team of Manufacturing Specialists that conduct comprehensive investigations to determine root cause, product impact and implement thorough and effective corrective and preventative actions. Manage, train and mentor a team of Manufacturing Specialists that generates manufacturing procedures and records, procures and enrolls manufacturing equipment, defines equipment maintenance requirements and spare parts, drives operational excellence initiatives, and performs other activities as responsible system owners. Drive process improvement initiatives, troubleshoot issues, track and trend metrics, and author/review/approve technical documents, procedures, deviations, CAPAs, and change controls. Supervise, coach, mentor, and train team members to maintain educated, qualified, and motivated employees. Minimum Requirements Bachelor's degree in a related scientific or engineering discipline with 20+ years biopharmaceutical industry experience and/or training or equivalent 7+ years prior leadership/supervisory experience Demonstrated knowledge of biopharmaceutical manufacturing processes 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 while working in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Fluent in reading and writing the English Language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch production records. Ability to write routine reports and speak effectively to groups of people. 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. Ability to develop and solve algebraic and exponential math problems by hand or using software. Ability to apply basic statistics to sets of values and develop and interpret different types of graphs. Ability to use computer software - (MS Office, ERP, EDMS, etc) Ability to use production equipment, laboratory equipment, office equipment 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. 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.
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