Sr. Manager - IT

Celltrion Branchburg, LLCBranchburg Township, NJ
21h$114,000 - $152,000

About The Position

As an IT Manager, you will be responsible for providing IT support to Manufacturing areas specifically focusing on safety, quality, and manufacturing performance. You will provide daily supervision of an IT area and be responsible for supporting Manufacturing production timelines and department goals. Your responsibilities will include IT planning activities, setting schedules, coordinating interactions and services from other groups, internal and external, to the manufacturing organization, and assigning daily work tasks. In addition, you will be hiring, developing, coaching/leading, and training IT resources based on your previous technical experience in supporting IT systems.

Requirements

  • This role requires flexibility and ability to make critical decisions 7 days/week. This position requires wearing clean room attire.
  • Strong understanding\experience supporting business critical applications such as MES (Manufacturing Execution Systems), LIMS (Laboratory Information Management Systems), and Industrial Automation Applications.
  • Basic understanding\experience supporting IT platforms and databases (Oracle, SQL, etc.), operating systems (Windows, etc.), and Cisco Infrastructure. Basic understanding of CSV (Computer system Validation) & SDLC deliverables.
  • Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.
  • Ability to work on multiple concurrent project initiatives.
  • Strong customer orientation and able to manage customer expectations.
  • BS/BA in Computer Science, Information Technology or related technical field required with a minimum for 2+ years supporting MES (Manufacturing Execution Systems)
  • Minimum of 2+ years supporting and managing an IT team
  • Minimum of 5+ years of experience in the pharmaceutical or biotechnology industry.

Nice To Haves

  • Project management skills.
  • Skills in communication, conflict resolution and managing complexity with exceptional skills to communicate decisions effectively, clearly, and accurately to staff and upper management.
  • Effective problem-solving and analytical skills to resolve operational problems.
  • Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations.
  • Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
  • Speak up with ideas, concerns and to ensure safety of others.
  • Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
  • Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
  • Strong collaboration with colleagues at all levels.
  • Demonstrate courage and integrity.
  • Demonstrated success in influencing without authority.
  • Strong customer service and teamwork oriented.
  • Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
  • Highly flexible, adapting to changes in priorities, requirements and processes is required.
  • Working knowledge of Lean/Agile processes and project management methodologies.

Responsibilities

  • Provide supervisory functions & demonstrate technical experience for the IT staff; manage and oversee the IT day-to-day support of Manufacturing Execution Systems and multiple IT systems. Ensure the delivery, support, maintenance, security, computer system validation documentation, and system administration of these systems with minimal impacts to key business areas.
  • Provide oversight on IT services and project tasks performed. Coordinate and allocate resources for daily operations and projects
  • Provides oversight for all aspects of IT Manufacturing Operations including Multi-Tiered Support, Escalation Management, Change Management GxP and Non-Gxp, Incident Management, Lifecycle Management, and Cyber-Security.
  • Lead staff meetings, setting priorities, planning process, and assigning work.
  • Ensure IT activities comply with cGMP guidelines. Follow all documentation and standard operating procedures. Set priorities, process execution, work assignments, and reprioritize as required.
  • Act as a liaison between business areas and IT staff.
  • Monitor Manufacturing execution systems metrics on a regular basis to ensure Operational Excellence.
  • Conduct and/or support deviation investigations
  • Serve as area advocate in cross functional meetings.
  • Champion company policies to area staff.
  • Contribute and adhere to safety, environmental, quality, and standards of the Corporation.
  • Communicate safety, status of IT operations, and employee related issues in a timely manner to management.
  • Coordinate the development, training, and exercise of a disaster recovery\business continuity plans.
  • Expect and act with speed and simplicity.
  • Being an engaged member of the IT leadership team and having an appropriate presence supporting Manufacturing Operations
  • Ensuring open lines of communication and clear messaging at all levels.
  • Measure and appraise IT resource performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
  • Train personnel in IT processes/operations following standard operating procedures and cGMP guidelines.
  • Mentor/coach staff as well as lead staff with a high level of honesty and integrity.

Benefits

  • paid time off (holidays, vacation, and additional leave)
  • medical, dental, and vision insurance
  • life insurance
  • a company-matched retirement savings plan
  • wellness programs
  • short- and long-term disability benefits
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