Job Number: 8579
This position is responsible for managing and directing activities and personnel related to Analytical Development in support of Product Development and Operations.
Manages and/or coordinates analytical method development, validation and transfer, of raw material, finished product, and cleaning validation test methods. This includes providing input into time and materials for new projects with business development, and managing these activities to ensure efficient operation.
Coaches and trains analysts and provides instrumental and analytical expertise to enable analysts to perform quality work in a time efficient manner.
To ensure a safe work environment for self and others through training, proper handling of chemicals and maintaining good housekeeping conditions.
Assists in the development and revision of methods, specifications, and other documentation related to Product Development functions to comply with Company and FDA guidelines. This includes writing and updating test methods and specifications for raw materials, intermediates, and finished product, standard operating procedures and change requests as required.
Writing and revising analytical method validation/transfer and cleaning validation protocols and reports.
Conduct laboratory and laboratory equipment investigations in the area to thoroughly document atypical and out of specification results through approved investigation and non-conformance reports. Ensure methods and SOP s are up to date, concise and reflect GMP s and GLP s.
Support facility technical operations in GMP related issues and continue to pursue expertise and personal development. This includes providing analytical support and expertise in support of the Baudette Facility Operations. Continue to develop expertise in GLP and new technologies pertaining to Quality Control and Analytical Development in support of Baudette Facility Operations.
Performs other duties as assigned or requested.
Project and Process Management
Quality Standards and Best Practices
Bachelor's Degree in Chemistry/Biochemistry
Education, training, or certification in Management and Leadership is preferred.
Minimum of 10 years experience in a Pharmaceutical Quality Control and/or Analytical Development Environment.
Demonstrated expertise of cGMP s and GLP s
Sound knowledge of method development/validation and method transfer requirements
Knowledge of stability guidelines and regulations
Competency in team building, problem solving, planning and initiative.
In-depth knowledge of laboratory instrumentation.
Ability to follow, prepare and explain technical matters and procedures.
Ability to make decisions independently after appropriate input from areas that will be affected.
Ability to manage multiple projects and competing priorities.
Ability to perform under stressful situations
Excellent leadership, communication, and interpersonal skills.