Job Description
Pharma Medica Research (PMRI) is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. We are a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We are currently searching for aBioanalytical Production Manager to join our lab operations team.The Production Manager is responsible for managing assigned bioanalytical projects including nonclinical and clinical studies, bioanalytical method development, method validation and study sample analysis at Pharma Medica Research Inc. ( PMRI ). Manage assigned laboratory technical staff and review all analytical data for accuracy, GLP, SOP and regulatory compliances. The position reports to the Lab Manager, Production/R&D and/or designate.Duties and Responsibilities:Responsible for tracking all assigned ongoing bioanalytical method development, method validation, non-clinical and clinical trial sample analysis. Under the supervision and support of Lab Management, the Production Manager allocates proper time frames for the completion of all assigned projects, as well as assuring that these time frames are met. Prior to receiving study samples, the Production Manager ensures that all laboratory personnel involved in the assigned project are trained on the analytical method. The Production Manager will also assure that all supplies for the study are ordered, pools and randomization charts are prepared before the first day of analysis. The Production Manager will prepare BVP / BSAP and setup project in LDMS prior to start project. The Production Manager must understand and ensure that the laboratory staff under his/her supervision operate according to regulatory agency guidelines, GLP procedures, Laboratory and PMRI SOPs, clinical study protocols, and BVP / BSAP. The Production Manager will be responsible for verifying all raw data generated from bioanalytical studies, and communicate any problems or deviations to the Principal Bioanalytical Investigator/designate. The Production Manager must address all audit findings for completed validations and studies to ensure the study completion timelines are met. The Production Manager should bring forth suggestions or recommendations that will improve laboratory organization and operations, including project management, SOP implementation and revision. The Production Manager will ensure that the Laboratory Management is kept up to date regarding raw data, instrumentation and calibration within the laboratory. Other duties as required.Qualifications: B.Sc. or a Community College Diploma in Chemical Technology or a suitable related scientific area. 3-5 years of Bioanalytical experience Excellent knowledge of equipment, instrumentation, trouble shooting, GLP, HPFB and FDA guidelines. Good communication skills, both verbal and written Knowledge of spreadsheets and word processing software are an asset Good interpersonal skills Ability to work both independently and as a team member This position requires the individual to have leadership qualities, in developing a team of individuals capable of producing a high quality throughput of bioanalytical measurementsIf you're interested in this exciting position, apply today!