Job descriptionThis position is responsible for supervising a team of technical employees providing bioanalytical laboratory support services (50% of effort) and performing bioanalytical analysis to support studies (50% of effort). Supervision responsibilities include providing direct oversight and supervision to the assigned team of technical resources by providing daily work instruction, monitoring technical capacity, identifying training needs, providing training, approving timesheets, writing and conducting employee performance reviews, ensuring all tools are available to conduct work, and upholding all safety and regulatory standards. The supervisor will work closely with the department manager/director and human resources to properly address any employee performance issues. The incumbent will develop a highly efficient, profitable, and quality oriented team, while providing subordinates with opportunities for professional growth. Analytical runs will be performed to support method development, validation and sample analysis studies as necessary.
Work with the Site Director and Project Managers to schedule resources to meet client deliverables.
Attend study meetings and consult with project managers to ensure project requirements are understood and are communicated to staff.
Ensure schedules are prepared and disseminated to staff and work is adequately executed.
Build a team of technical resources able to flex between various service lines as needed.
Identify and addresses training needs throughout the team.
Review and verify data and documentation generated by other staff as assigned.
Upholds all safety and regulatory standards.
Monitor capacity (people and equipment) within the team and works across teams as necessary to supplement capacity gaps.
Contributor in the execution of project work.
Create culture that values teamwork and holds people accountable.
May be asked to serve on internal ad hoc committees.
Works with Department and HR leader to address team talent needs including hiring, training, advancing, appraising, motivating, disciplining, and assuring healthy and safe working conditions of staff members.
Responsible for ensuring the appropriateness of time and materials charged to projects.
Implements and observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, study protocols, and analytical plans.
Serves on Site Safety Committee, implements and observes appropriate safety and health practices including personal protective equipment (PPE) and safe laboratory practices.
Perform analysis including method transfer, development, validation and sample testing in support of bioanalytical studies.
Performs work under regulated conditions (GLP, GCP, CLIA) as required.
Perform other duties as may be required.
BA/BS in biological or physical Sciences and at least 7 years of relevant experience; or,
MS in biological or physical sciences and at least 5 years of relevant experience.
Must have at least 3 years prior experience as a direct supervisor.
At least 3 years prior experience working in a GLP environment.
Experience and knowledge of Ligand-binding assays (e.g. ELISA/MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is required.
Ability to work safely with potentially hazardous substances and exercise universal precautions.
Work requires some standing and sitting for long periods of time, including working within a laboratory hood or at a laboratory bench.
Expert pipetting skills.
Knowledge of Watson LIMS a plus.
Immunochemistry / Immunoassay / Bioanalytical Scientific bench experience.