Key Responsibilities
* Serve as the subject matter expert for data management systems used in laboratory settings, encompassing LIMS, Waters Empower, LabX, Softmax Pro, and other related software.
* Bolster the development of IT systems to support Tech Transfer/Commercialization and manufacturing of Biologics, ensuring adherence to cGMP and SDLC standards such as change control and document management.
* Implement industry best practices for Laboratory Systems processes that facilitate sample management, testing, and validation.
* Maintain site Laboratory Systems in compliance with evolving GMP requirements and trends worldwide.
* Provide training to relevant personnel on the proper utilization of site Laboratory System procedures.
* Contribute to proactive processes to guarantee continuous effectiveness of Laboratory Systems, including Change Controls, Documentation Management, CAPAs, and Audit Readiness.
* Pursue ongoing improvement of Laboratory Systems, identifying and incorporating efficiencies as necessary from a systematic and compliance perspective.
* Offer SME support for general troubleshooting, problem-solving, technical guidance, and direction to address overall business needs.
* Foster an environment of 'right first time' through focus on principles of lean, including simplification, standard work, visual management, and a learning organization.
Qualifications and Experience
* Degree qualification in a Technical discipline (e.g., Biochemistry, Chemistry, Engineering).
* A minimum of 2-3 years' experience in Laboratory Systems.
* Previous experience with configuring, building, maintaining laboratory management systems like LIMS, LabX, Empower systems.
* Understanding of analytical methodology (e.g., HPLC, ELISA, Glyco analytic, Bioassays, PCR, capillary electrophoresis, compendial assays).
* Familiarity with GMP, ICH, USP, and global compendia regulations and guidelines, particularly regarding analytical method development and validation.