MANAGER, ANALYTICAL CHEMISTRY (LC-MS/MS)
The position oversees a broad range of analytical and bioanalytical chemistry methods needed to support nonclinical and clinical studies for various scientific programs in CRO Services with responsibility for oversight of project scheduling and staff adherence to the quality and safety standards within the division. The Manager, Analytical Chemistry (LC-MS/MS) functions as a subject matter expert and has oversight of the scientific elements to ensure the successful implementation and/or sustainability of the program. This position is the primary point of contact for Project Management, Scientific departments, Laboratory Operations, Business Support, and other staff for addressing small molecule biological testing and procedure needs using standard scientific methods. This position directly supervises other scientists.
Essential Duties & Responsibilities
- Provides oversight, planning, designing, development, and validation of GLP-compliant, Bioanalytical LC-MS/MS methods for quantification of drugs and metabolites in biological matrices to support pharmacokinetic, toxicokinetic, and ADME studies of novel small molecules.
- Responsible for the formulation analysis processes which include ensuring the analytical systems are properly qualified maintained and employed to provide supporting dose formulation analysis data for all in vivo studies.
- Acts as the system administrator for various laboratory software systems including, Watson LIMS, Waters Empower 3, ABSciex Analyst, and Water's Acuity UPLC System.
- Provides oversight and coordination in the establishment of a range of collaborative laboratory and/or scientific research projects.
- Prepares reports that can be included as contributing scientist reports on the final study report.
- Oversees scheduling of all analytical/bioanalytical services to ensure project timelines are met.
- Oversees day-to-day resource allocation and forecasting of staff utilization within small molecule bioanalytics.
- Oversees development of staff and maintains a cross-training matrix to train, develop, and effectively utilize all small molecule personnel in collaboration with project leaders, scientific subject matter experts, and project management team members.
- Forecasts and implements new training activities based on future work.
- Supervises and manages assigned staff.
- Performs capacity planning and scheduling of assigned resources with the scheduling analyst, project leaders, and the management team.
- Manages scientists including hiring, training, advancing, appraising, motivating, disciplining, and assuring healthy and safe working conditions of team members. Works with HR business partners to implement HR processes and other administrative responsibilities associated with the direct supervision of professional and technical resources of the functional group while adhering to core organizational behaviors.
- Ensures laboratory equipment is operational and maintained to optimum operating conditions at all times.
- Establishes budgets for areas of responsibility. Works within established budgets. Upholds all safety standards, discipline guidelines, and regulatory compliance requirements with all assigned staff.
- Maintains the scientific integrity of the data produced by assigned staff.
- Maintains effective communication between assigned staff and other departments.
- Communicates department issues and provides status updates to the management team.
- Manages purchasing and approval of laboratory supplies.
- Oversees timesheet submittal and approval to ensure appropriate billing and % utilization coverage.
- Oversees daily activities of staff to ensure appropriate documentation and adherence to SOPs and safety standards.
- Utilizes daily observations to recommend and potentially drive modifications (with scientific approval) to forms and SOPs.
- Re-trains staff as necessary to ensure appropriate conduct of the assays.
- Holds staff accountable, consistently across all groups to ensure performance and quality.
- Responsible for oversight of equipment related validations, IQ/OQ/PQ, monthly/quarterly/annual/ verifications and ensures a unified expectation across the department.
- Develops/Reviews/ Implements processes involved to streamline, improve science/compliance and increase efficiencies.
- Provides support for collection, analysis, and interpretation of data.
- Provides technical expertise, consultation, and leadership to scientific professionals and collaborators within area of specialty, as needed.
- Oversees and coordinates the setup, operation, maintenance, and troubleshooting of the program's equipment, instrumentation, and facilities.
- Assists with the development and implementation of new research concepts, protocols, and procedures within the field of specialty, applying diversified knowledge of relevant scientific principles, practices, and methods.
- Maintains current knowledge of technological developments and industry trends; identifies current and future technology needs, and introduces and establishes innovative technology to directly support ongoing research activities.
- Perform miscellaneous job-related duties as assigned.
- Education and Experience:
- Ph.D. degree in chemistry or other related discipline, or
- Master's degree in chemistry or related discipline and 7 years' prior relevant experience, or
- Bachelor's degree in chemistry or related discipline and 10 years' prior relevant experience.
- Must have a minimum of 4 years' prior experience managing projects.
- A minimum of five years' prior experience managing staff.
- Possess extensive experience with and knowledge of LC-MS/MS, and dose formulations analysis applications.
- Demonstrated ability to manage multiple concurrent projects, timelines, and budgets.
- Prior experience developing, implementing, and monitoring training programs.
- Demonstrated ability to create and motivate teams to accomplish successful outcomes.
- Experience managing client relationships; customer-focused orientation.
- Experience building collaborative and strategic relationships to leverage organization resources.
- Ability to wear Personal Protective Equipment (PPE) including an N95 respirator or PAPR for extended periods of time.
- Ability to meet all entry requirements, including medical and vaccination requirements, to work in A/BSL-2 environment.
- Prior experience in implementing, maintaining, and executing laboratory operations project work under regulatory requirements.
- Knowledge of GLP preferred.
- Experienced with various equipment and laboratory management systems.
Work Environment & Conditions
This position works in an BSL-2 laboratory environment and requires the use of personal protective equipment (PPE) including (but not limited to):
- Eye protection (Safety glasses and/or full-face shield)
- Respirator (varies based on tasks and barrier requirements)
- Tyvek/scrub suits
- Nitrile (or equivalent) gloves (varies based on tasks)
- Hearing protection (varies based on tasks)
Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.
- Ability to stand for extended periods of time
- Ability to sit for extended periods of time.
- Ability to work in a biosafety environment.