Job Description
We are seeking a skilled Laboratory Systems Lead to support the implementation and configuration of laboratory systems. This role will involve working with laboratory teams to test incoming raw materials, in-process products, drug substance/drug product, and stability samples.
Key Responsibilities
* Serve as a subject matter expert on data management systems for instrument control in laboratories.
* Build and maintain lab IT systems to support tech transfer/commercialization and manufacturing of biologics.
* Monitor and support the performance of site laboratory systems according to cGMP and SDLC standards.
* Implement industry best practices specific to laboratory systems processes that support sample management, testing, and validation.
* Ensure site laboratory systems comply with changing requirements and trends in worldwide GMPs.
* Deliver training to relevant personnel on the correct application of site laboratory system procedures.
* Proactively participate in processes to ensure laboratory systems continue to function effectively.
Requirements
* Degree qualification in a technical discipline (e.g., biochemistry, chemistry, engineering).
* At least 2-3 years of experience in laboratory systems.
* Previous experience with configuring, building, and maintaining laboratory management systems (e.g., LIMS, LabX, Empower systems).
* Understanding of analytical methodology (e.g., HPLC, ELISA, glyco-analytic, bioassays, PCR, capillary electrophoresis, compendial assays).
* Working understanding of GMP, ICH, USP, and global compendia regulations and guidance.