KBI Biopharma Inc.
Director, Manufacturing Technical Operations
KBI Biopharma Inc., Durham, North Carolina, United States, 27703
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.
Team members also serve as the primary point of contact for equipment issues and inventory management issues.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.
Additionally, the Director is responsible for performance metrics and oversight for all manufacturing systems.The Director is responsible for ensuring their staff works cross-functionally with QA, MS&T, Engineering, Supply Chain, IT, AFS and other key departments to ensure manufacturing operations are successful, reliable, and compliant. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.**Responsibility**enerates manufacturing procedures and records, procures and enrolls manufacturing equipment, defines equipment maintenance requirements and spare parts, drives operational excellence initiatives, and - Bachelor's degree in a related scientific or engineering discipline with 20+ years biopharmaceutical industry experience and / or training or equivalent* Energetic, motivated, and dynamic individual.* Must be organized and able to focus while working in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.* Fluent in reading and writing the English Language.* 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* 7+ years prior leadership/ supervisory experience* Demonstrated knowledge ofbiopharmaceutical manufacturing processes ispreferred.Experience in single-use platform technology ispreferred. - Excellent written and verbal communication skills arerequired.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.At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.
Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position.
KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement. #J-18808-Ljbffr
Team members also serve as the primary point of contact for equipment issues and inventory management issues.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.
Additionally, the Director is responsible for performance metrics and oversight for all manufacturing systems.The Director is responsible for ensuring their staff works cross-functionally with QA, MS&T, Engineering, Supply Chain, IT, AFS and other key departments to ensure manufacturing operations are successful, reliable, and compliant. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.**Responsibility**enerates manufacturing procedures and records, procures and enrolls manufacturing equipment, defines equipment maintenance requirements and spare parts, drives operational excellence initiatives, and - Bachelor's degree in a related scientific or engineering discipline with 20+ years biopharmaceutical industry experience and / or training or equivalent* Energetic, motivated, and dynamic individual.* Must be organized and able to focus while working in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.* Fluent in reading and writing the English Language.* 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* 7+ years prior leadership/ supervisory experience* Demonstrated knowledge ofbiopharmaceutical manufacturing processes ispreferred.Experience in single-use platform technology ispreferred. - Excellent written and verbal communication skills arerequired.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.At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.
Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position.
KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement. #J-18808-Ljbffr