**Job Description**: We are seeking a skilled Laboratory Systems Lead to support the implementation and configuration of Laboratory Systems. This individual will be responsible for supporting laboratory teams for testing of incoming raw materials, in-process, drug substance/drug product, stability samples.
The ideal candidate will have expertise in data management systems for instrument control in laboratories, including LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
This role will involve building lab IT systems to support tech transfer/commercialization and manufacturing of biologics, monitoring and supporting the performance of site laboratory systems according to cGMP and SDLC standards.
The successful candidate will also be responsible for implementing industry best practices specific to laboratory systems processes that support sample management, testing, and validation.
Additionally, this individual will ensure site laboratory systems comply with changing requirements and trends in worldwide GMPs.
They will deliver training to relevant personnel on the correct application of site laboratory system procedures and proactively participate in processes to ensure laboratory systems continue to function effectively.
A collaborative approach is required to resolve obstacles and maintain a highly effective and productive functional group.
Required Skills and Qualifications
* Bachelor's degree in a technical discipline, such as biochemistry, chemistry, or engineering.
* At least 2-3 years of experience in laboratory systems.
* Previous experience with configuring, building, and maintaining laboratory management systems, such as LIMS, LabX, and Empower systems.
* Understanding of analytical methodology, including HPLC, ELISA, glycoanalytic, bioassays, PCR, capillary electrophoresis, and compendial assays.
* Familiarity with GMP, ICH, USP, and global compendia regulations and guidance.
Benefits
This role offers an excellent opportunity for professional growth and development in a dynamic and award-winning pharmaceutical organization.
Others
If you are interested in this position, please feel free to contact Rachel Kent at Life Science Recruitment for further information.