Director, Laboratory Architecture and Software

Contact: Kevin Mednick
Phone: (215) 658-1379

Position Overview

Our client is a premier CDMO with over 65 years of sterile injectable experience.

As the Director of Laboratory Software and Systems, you will play a critical role in leading and implementing technologies to enhancing our lab’s productivity, quality, and throughput through the utilization of software and the implementation of digital technologies. The role involves strong communication and collaboration with Quality, Regulatory, R&D, and production laboratory groups in a fast-paced biopharmaceutical environment to gather business and functional requirements and deliver applications and technology solutions that improve and support business processes and our laboratory’s growth. You will be accountable for architecting, testing and documenting system changes as required by GMP and ISO standards. Your ability to translate the requirements of our internal customers into robust solutions will be essential in this role.

Key Responsibilities

  • Role Responsible for the design and support of the LIMS supporting laboratory operations to include, but not limited to, systems analysis, process & procedure creation, customized reports, modifications, user account management, barcode/printer management, and upkeep of systems administration tasks.
  • Lead and coordinate LIMS Super Users, LIMS Admins, offshore support and Help Desk for all laboratories applications.
  • Drive and support data integrity processes for all laboratory related software applications.
  • Collaborate with the QA department to support the GMP/ISO accreditation processes through validation activities; develop and/or execute test scripts as required.
  • Lead and oversee development of Standard Operating Procedures, User Guides, and other relevant documentation for the LIMS and related applications.
  • Collaborate with management and other IT staff on business requirements to ensure adequate infrastructure support to lab systems including all upgrades to hardware and software.
  • Participate in internal and external audit reviews of the system and other lab IT related topics.
  • Lead laboratory systems upgrades and maintenance on a frequent and recurring basis while complying with GxP requirements.
  • Provide vendor management support by working with the vendors on implementation, future upgrades, modifications, and other laboratory business needs.
  • Provide high-level project management for any LIMS projects using best practices for change control and security of systems.
  • Manage effective data exchange between LIMS and all lab instruments and other associated systems.
  • Directs and controls the strategic software/informatics roadmap to balance regional, business unit, and corporate goals.
  • Provides leadership in problem solving, which requires the consideration of the IT strategic plan and short term goals, the means by which to solve the problem, and development of associated action plans.
  • Creates and maintains technical documentation and architecture diagrams as required.
  • Assist in assessing the strategic direction of information technology and in developing strategic plans for use of new technology and application.

Key Requirements

  • Bachelor’s or Master’s degree in Information Technology or Computer Science or equivalent experience in an Information Technology environment.
  • A minimum of 8 years experience working within a regulated setting (Laboratory, Quality, Manufacturing, IT) is required.
  • Demonstrated experience and competency in understating the application of CSV and ALCOA+ regulations to laboratory systems.
  • Must have exposure to a broad group of Laboratory software systems and demonstrate command of the Laboratory software marketplace, software capabilities and functionality, and competitive differences between software packages
  • Must be able to demonstrate full understanding and knowledge of how Laboratory systems work, including LIMS, and demonstrate a comprehensive understanding of the systems architecture and data elements underlying these systems.
  • Systems discipline as an Information Technology Analyst, Laboratory Systems Manager, or a related function performing
    • User support
    • Training
    • Supporting installation, development, and maintenance of the business application software and servers, including the development of associated metadata and user interfaces
  • Successful LIMS implementation project management experience preferred
  • Preferred working and contemporary knowledge of Labware LIMS, Labvantage LIMS, Openlab ECM, IDBS ELN, Labware ELN, Chromelion, Empower, and numerous other chemical and microbiology labrotory devices and systems
  • Support large scale complex software application(s)
  • Experience with LabVantage and LabWare applications
  • Must have working knowledge of laboratory operations and experience with change control and software validation
  • Demonstrates diagnostic skills and expertise to assist with problem determination and solution across the enterprise solution environment.
  • Create and meet deadlines
  • Deal with multiple high priority issues simultaneously
  • Develop and manage projects of significant scope with considerable impact on the organization
  • Deal with controversial or sensitive issues, Interactions require communication strategy and persuasion skills in negotiating extremely critical matters.
  • Effectively manage, mentor, and grow a global team.
  • Perform analysis at a high level
  • Excellent written and oral communication skills
  • Ability to work in a fast-paced environment to meet client and internal demands under tight timelines.

Location(s)

NJ

If interested, please send a MS Word version of your resume to [email protected]

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