Job Title
Group Leader - Evening Shift, Biopharma
The Group Leader - Evening Shift is a critical role in our Biopharma department, responsible for providing management and direction to a group of laboratory staff.
This individual will be tasked with allocating, scheduling, and leading laboratory resources for project activities, updating LIMS for project status, and reviewing timesheet reports for billing accuracy.
The Group Leader will also be responsible for preparing, reviewing, and approving study protocols, project status reports, final study reports, and other project-related technical documents.
In addition, this role will involve designing experimental studies, participating in technical troubleshooting, and reviewing data for technical quality and compliance to protocols, methods, and SOPs.
The Group Leader will also assist in client and regulatory authority audits, respond to client questions and needs, lead client technical meetings, and prepare proposals, project definitions, and pricing.
Furthermore, this individual will coordinate and prioritize project activities with internal functional groups and support functions, and assist senior group leaders and/or managers in their responsibilities.
The Group Leader will also be responsible for preparation and implementation of SOPs and company operational policies, ensuring adherence and making recommendations for quality system improvements.
Requirements:
* Education: Bachelor's degree in a relevant area, such as chemistry or biochemistry.
* Experience: Previous experience in the pharmaceutical, biotech, or analytical contract laboratory industries, with at least 5 years of comparable experience or an equivalent combination of education, training, and experience.
* Leadership responsibility: At least 1 year of leadership responsibility.
Skills and Abilities:
* Management experience in the pharmaceutical, biotech, or analytical contract laboratory industries.
* Stability/QC/analytical R&D/project and program management.
* Direct supervision of technical staff.
* Full understanding of GMP requirements, client SOPs, ICH guidelines, EP, and USP requirements, EMA, and FDA guidance.
* Knowledge and experience of a wide range of techniques, including HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.