Group Leader, Bioassay

Job Description
Responsibilities include:
Supervise daily laboratory activities and laboratory scheduling to ensure optimum group performance.
Provides guidance, support, direction and leadership to technicians and analysts through positive interactions with all personnel during daily operations.
Responsible for the analysis of samples to determine microbiological quality through the following analyses:
Microbial enumeration methods, absence of specified microorganisms, and endotoxin.
Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
Coordinates the scheduling of personnel to maximize productivity.
Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
Coordinates and communicates delays and technical issues with management in a timely manner.
Devises and develops processes and methods for the solution of technical problems.
Responsible for system maintenance and calibration to ensure equipment is operating within specified requirements.
Trains, mentors and supervises analysts (microbiologists).
Reviews lab investigations and deviations with analysts/microbiologists.
Conducts root cause analysis and implements solutions in collaboration with the chemists.
Performs statistical analysis of data and evaluates the area supervised for microbiological trends, and responds appropriately.
The ideal candidate would possess:
5+ years related experience in Gene and Cell Therapy preferred.
Previous leadership experience preferred.
Knowledge of cGMPs and related compliance regulations and guidance(s) required.
Knowledge of RT-PCR, flow cytometry and cell based methodologies.
Must have experience with the various products and services including stability studies, method development and validation, LIMS, and ELN.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills;
who is able to assume aleadership role in the laboratory;
and, who is able to effectively interact with all departments within the company and with client personnel.
Demonstrated skills in laboratory techniques.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software