Leadership Role in Laboratory Systems
This is an exciting opportunity for a talented professional to take on a leadership role in laboratory systems. The successful candidate will be responsible for implementing and configuring laboratory systems, supporting laboratory teams, and ensuring compliance with regulatory requirements.
* SME on data management systems for instrument control in the laboratories, including LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
* Build the lab IT systems to support tech transfer/commercialization and manufacturing of biologics. Monitor and support the performance of the 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.
* Evaluate and 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 that laboratory systems continue to function effectively and improvement/remediation actions are taken as needed.
* Identify and implement efficiencies in laboratory systems from a systematic and compliance perspective.
* Provide SME support for general troubleshooting, problem-solving, technical direction, and guidance to support overall business needs.
Key Responsibilities
* Configuration and implementation of laboratory management systems.
* Support laboratory teams for testing of incoming raw materials, in-process, drug substance/drug product, stability samples.
* Maintenance and optimization of laboratory systems.
* Development and implementation of process improvements.
* Ensuring compliance with regulatory requirements.
Required Skills and Qualifications
* Bachelor's degree in a technical discipline (Biochemistry/Chemistry/Engineering).
* At least 2-3 years' experience in laboratory systems.
* Previous experience with configuring, building, and maintaining laboratory management systems.
* Understanding of analytical methodology (HPLC, ELISA, Glyco analytic, Bioassays, PCR, capillary electrophoresis, compendial assays).
* Familiarity with GMP, ICH, USP, and global compendia regulations and guidance.
About the Role
This is an excellent opportunity for a skilled professional to take on a leadership role in laboratory systems. If you have a passion for technology and a desire to work in a fast-paced environment, we encourage you to apply.
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