To provide advanced technical research skills and establish test methods and procedures under the direction of Department Chairperson or Research Scientist (Faculty).
DUTIES AND RESPONSIBILITIES
Oversees cGMP Laboratory Operations
Plans, directs and coordinates laboratory projects with customers.
Determines specific goals objectives to be attained.
Assigns and reviews work of production staff.
Oversees production teams
Establishes and maintains quality control of cGMP operations.
Assists customers with planning of cGMP operations
Reviews regulatory updates
Incorporates FDA regulatory updates as required.
General Laboratory Duties
Defines problems and possible solutions
Maintains records for supply inventory, facility parameters, other required elements of cGMP production facility and production products.
Safety and Regulatory Compliance
Writes and maintains regulatory and safety SOP's for facility
Adheres to and assists with customizing of TMH & TMHRI Safety Procedures for cGMP Facility
Manages and maintains records for Quality Assurance.
Demonstrates the components of the ICARE values statement.
Follows safety rules while on the job. Reports accidents promptly and corrects safety hazards. Compiles all hospital required and job-related in-services and applies the information needed
Performs other duties as assigned.
MS with 5+ years experience
Terminal Degree with
Methodist Hospital System - 15 months ago