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

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. Oversee the team as they take responsibility for performing area walkthroughs and manage inspection readiness and audit responses and 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.  Ensure staff maintain a high level of compliance to procedures and quality expectations. 
  
  
  

Minimum Requirement

• 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 face-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. 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.

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 to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.