Senior Director, Laboratory Sciences

CareAbout•Columbia, MO

About The Position

The Senior Director of Laboratory Sciences is responsible for directing the Laboratory Services organization by providing administrative and scientific leadership to ensure the attainment of operational goals and participate with the executive management team in formulating current and long-range plans, objective and policies by performing the essential job responsibilities.

Requirements

MS degree in chemistry or biology and 7+ years working in analytical or preclinical research; PhD in chemistry and 5+ years in analytical or preclinical research; Equivalent training and experience considered
5+ years related experience required
Advanced computer skills including Microsoft Office suite
English proficiency required to read and interpret documents such as safety rules, operating and maintenance instructions, software manuals, study documents, and procedure manuals, to write routine reports and correspondence, and to speak effectively before groups of customers or employees of the organization
Advanced mathematical and statistical skills related to scientific and business data for interpretation and presentation to staff and upper management
Understand, and improve upon, a variety of instructions furnished in written and oral form and translate instructions for staff
Lead diverse group of scientists, researchers and documentation specialists

Responsibilities

Act as the testing facility management for applicable validation and sample analysis studies, i.e. the person responsible for ensuring that the bioanalytical phase of studies are conducted according to the applicable principles of GLP
Monitor level of GLP compliance, study schedules, review and monitoring of study organization, process improvement and adherence to SOPs
Assure the development, review, revision and implementation of SOPs, SSPs, policies, training manuals and/or checklists related to technical procedures, facility issues, and date generation
Assign study staff as appropriate to meet study objectives
Designate study director, principal scientist, contributing scientist, responsible scientist, or principal investigator to meet study objectives
Replace the study director, principal scientist, contributing scientist, responsible scientist, or principal investigator promptly if it becomes necessary to do so during the conduct of a study
Direct and manage departmental resources, personnel and fiscal assignments and allocations
Act as company representative to outside agencies including: FDA and local regulatory agencies
Contribute to the resolution of quality assurance issues
Manage and ensure departmental directors, managers and supervisors are compliant with corporate directives
Confer with scientists regarding research and review technical papers and reports
Attend planning meetings as well as develops and expands laboratory analytical capabilities
Identify and implement techniques and instrumentation to increase efficiency in sample preparation, handling, analysis and reporting
Administrate instrumentation and software qualification and validation
Represent laboratory services interests on IT hardware/software teams (e.g. LIMS)
Monitor the quality of data entered and calculated by the departments
Review and assignment of staff reporting structure
Stay informed on current scientific and regulatory issues by reviewing scientific literature and attending scientific meetings
Travel to clients and professional meetings to present scientific papers and capabilities of testing facility’s laboratory services program(s)
Travel to professional meetings to present scientific papers and represent testing facility
Travels to client companies to present capabilities of testing facility
Review and interprets complex analytical data
Authorize and approve departmental purchases
Attend and oversee committee meetings