Sr. Manager MES Operations

Posted 4 Days Ago
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National, MD
133K-184K Annually
Senior level
Biotech
The Role
The Sr. Manager MES Operations will lead the implementation and management of manufacturing execution systems (MES) and other IT solutions in a regulated industry. Responsibilities include technical guidance, team management, Agile collaboration, and ensuring compliance with regulatory standards.
Summary Generated by Built In

Job Summary:

The Manager/Senior Manager 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:

  • (Manager 7+, Senior Manager 10+) 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
  • (Manager 2+, Senior Manager 5+) 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

Salary Range:

$133,000 - $183,700

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. 

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.

Top Skills

Agile
Mes
The Company
Boulder , CO
1,282 Employees
On-site Workplace
Year Founded: 1996

What We Do

KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.

With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.

KBI is proud to be a JSR Life Sciences Company.

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