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Job Title :
Manager, Research and Technical Director
Department :
Pharmacy Pharmaceutics and Pharmacology
The Technical Director of the Pharmacoanalytical Shared Resource (PhASR) will directly supervise managers and individual contributors who are conducting research studies to support users of PhASR services, as well as manage relationships with OSUCCC leadership, college departments, external sponsors, clinical and non-clinical investigators, suppliers, and contractors as they relate to PhASR studies.
The Technical Director will direct and oversee the operational research and activities of PhASR staff for clinical and non-clinical research studies.
Responsibilities Include :
Participates with PhASR and OSUCCC leadership in the short and long-term strategic planning activities
Disseminates plans and directives to investigators and their staff / trainees and to PhASR staff to effectively and efficiently carry out activities to meet established project goals and objectives
Disseminates plans and directives to PhASR staff to effectively and efficiently meet established strategic goals and objectives
Serves as lead liaison with investigators to monitor project portfolios, staff workload and quality of services
Determines and assigns actions to address problems with follow-up to ensure compliance in the conduct of GLP and non-GLP research and adherence to FDA and protocol requirements
Oversees the coordination and management of project completion for clinical and non-clinical studies in accordance with protocol, CFR, FDA, and other internal and external regulatory and quality standards
Plans and oversees new and / or revised policies and procedures to address quality assurance issues and to meet requirements of new research protocols
Manages relationships with related entities including staff, investigators, physicians and laboratory and administrative staff as needed
Interfaces with external sponsors, monitors and auditors
Develops and implements processes among research staff for all clinical and non-clinical study-related activities including : development of detailed protocols, documentation, quality assurance, and follow-up as well as reporting
Ensures that all data on clinical and non-clinical samples for each study is recorded in a timely and appropriate manner
Directs all bioanalytical operations of the Pharmacoanalytical Shared Resource (PhASR) within the Comprehensive Cancer Center
Implements strategic plans for research consistent with the OSU Comprehensive Cancer Center in conjunction with the PhASR Director
Collaborates with research investigators to assist them in completing the specific aims of research projects as they relate to research design and measurement, regulatory compliance, data collection, and data management
Directs the development and execution of procedures for data collection and quality control
Designs and implements investigator and staff trainings for specialized sample collection, sample processing, data collection, data entry and management
Directs the hiring, training and oversight of PhASR staff
Oversees preparation of PhASR reports, progress reports of services completed for research projects conducted through the PhASR
Develops outcomes reports to evaluate the effectiveness of PhASR operations and services and recommends changes as needed
In addition to these broad managerial activities, the PhASR Technical Director applies in-depth knowledge of liquid chromatography-mass spectrometry and its application to ensure optimal use of PhASR equipment and staff time
Ensures maintenance of all laboratory equipment by directing routine maintenance and scheduled contracted maintenance services when necessary
Participates in conferences related to the progress of studies and presents PhASR capabilities and experimental data at local and national meetings
Prepares manuscripts and grant proposals to governmental and private agencies, including writing sections of investigator manuscripts and grant proposals
Completes all other activities as requested from the OSUCCC leadership and the PhASR Director in order to facilitate the research and service objectives of the OSUCCC
MINIMUM QUALIFICATIONS :
Bachelor’s degree or equivalent experience is required, Doctoral degree in an appropriate field with postdoctoral training is preferred.
Requires 5 years’ experience in bioanalytical chemistry, regulated laboratory experience (CLIA, CAP and / or FDA audits), and program management experience.
8-12 years’ experience preferred as a bioanalytical chemist with 5 of those in a regulated laboratory (CLIA, CAP, and / or FDA audits) and 2 years in program management.
Extensive mass spectrometry experience in quantitating small molecules in biological matrices.
Experience in industry, government, and university laboratories with considerable experience in a R & D setting (i.e., planning and conducting R & D projects / programs in terms of technical and managerial functions), extensive experience in FDA guidance for bioanalytical assay validation is required.
Requires successful completion of a background check; selected candidate may be asked to complete a pre-employment physical including a drug screen.
Function : Research and Scholarship
Sub function : Research
Career Band : People Leader Managerial
Career Level : M2
Explore our extensive benefits
Work-life : Flexible and remote work arrangement opportunities where applicable, childcare program, and access to educational, athletic and cultural events.
Retirement : State pension and alternative options with competitive employer contributions, as well as optional supplemental plans.
Health : Medical, dental, vision and prescription coverage, life insurance, flexible spending accounts and wellness programming.
Time off : Paid vacation and sick time, parental and medical leave plus 11 paid holidays. Short and long-term disability options also available.
Financial : Tuition assistance for employees and their dependents, adoption assistance and discounts with preferred vendors and university partners.
Wellness : Lifestyle spending account, employee assistance program, health reimbursement account, and employee wellness program.