Responsible for leading and supervising the QC Laboratory that performs analytical release and stability testing of clinical and commercial products according to approved test methods and protocols, cGMPs (current Good Manufacturing Practices) and current SOPs. The QC Laboratory Manager is responsible for the review and approval of raw data and results from the OC laboratory and approved contract laboratories. He/she monitors the stability program including protocols, set-up and sampling according to ICH/FDA guidelines and regulatory submissions/commitments. This person assures laboratory personnel are trained, qualified and properly equipped for safe and effective performance of their assigned duties. The job function includes encouraging a team environment to promote quality while continuously improving efficiency and productivity within the laboratory The position involves establishing communication with contract laboratories starting with qualification and analytical method transfer and continuing with routine testing to ensure that quality laboratory standards are maintained.
Responsibilities will also include, but are not limited to, the following:
Manages all activities associated with release and stability testing of clinical and commercial APIs and finished products. This includes scheduling/coordination of laboratory testing, data review and QC approval of results within specified timelines.
Supervises 9 laboratory analysts and 1 lab technician including performance evaluations/development, training on SOPs and approved test methods and hiring/promotion recommendations.
Responsible for the stability testing program including establishing stability protocols, sample set-up, monitoring and performing all testing according to defined schedules, guidelines and the required timelines.
Supervises method transfer and validation activities according to approved protocols.
Manages reference standards testing and recertification program.
Authors/reviews SOPs and analytical test methods, method transfer protocols/reports and stability reports.
Responsible for interacting with contract laboratories to ensure successful method transfers and that routine testing is performed to the same standards as in the OC laboratory.
Leads OOS investigations and initiates corrective/preventive action.
Participates in safety committee meetings and ensures compliance with all laboratory regulations including cGMPs, DEA and OSHA regulations and SOPs.
Monitors lab supplies budget and makes recommendations for capital equipment purchases.
Ensure laboratory readiness for and participate during regulatory inspections (FDA and DEA) and audits.
Minimum 8 - 10 years' pharmaceutical laboratory experience in quality control or analytical departments including prior supervisory experience.
BS/MS Chemistry or relevant discipline with equivalent experience
Demonstrated communication skills
Strong decision making & problem solving capability
Demonstrated management skills including delegation, time management, work allocation and people leadership