Associate Director, MES Operations

Job Summary:

The Associate Director of IT Manufacturing Systems will be instrumental in ensuring that the team meets KBI’s business objectives for implementing and managing world class MES, Process Trending, and other manufacturing solutions to the shop floor as part of KBI’s Digital Strategy.  Working as part of the Global OT Products Team and partnering with enterprise IT Leadership, Infrastructure, Architecture, Product Development, Manufacturing, Lab Systems, and Quality to execute strategy, design and implement industry best practices and solutions.  This is a hands-on role and will require execution of responsibilities at many different levels.

Job Responsibilities:

• Lead, manage and provide technical guidance to direct reports
• Execute on the digital strategy for the MODA-ES (MES), Process Pad, and other solution delivery to the KBI global manufacturing network
• Serve as or Provide input to the MFG System Product Owner in an Agile setting
• Understand business priorities and allocate resources to meet demand
• Ensure all team members adhere to documented System Development Life Cycle as well as relevant regulations, policies and standards
• Identifies root cause of issues and implements permanent solutions to prevent future occurrences Implements proactive monitoring to ensure early warnings and quick recovery
• Effectively communicate with all levels of management and across all functional areas regarding applicable IT priorities and project statuses
• Build and develop team supporting multiple offices with distributed workforce

Minimum Requirements:

• 13+ years of experience in a GMP regulated industry (Biologics and Cell Therapy preferred) working with MES systems (MODA, Syncade, Pas-X, Rockwell, Camstar)
• Experience in implementing IT solutions in a manufacturing environment
• 7+ years’ experience in leading or managing teams
• Experience as an Agile SCRUM Master, Product Owner, or team member in an Agile setting
• Solid understanding of GMP applications and associated regulatory requirements (Part 11 and Data Integrity)
• Knowledge of the IT system development life cycle and software quality assurance in a regulated environment
• Knowledge of general networking concepts and IT best practices
• Ability to work both independently and with teams at various levels in the organization
• Strong communication skills, both verbal and written as well as capable of presenting the right level of information to management
• Strong analytical and organizational skills

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.