- Manages a team of 60 professionals who are responsible for the installation and maintenance of analytical technology in a GMP laboratory. This team also installs and maintains sample storage equipment including walk in refrigerators and freezers.
- PPD maintains thousands of pieces of analytical equipment and over 150,000 cubic feet of sample storage space at the Middleton campus.
- Manages equipment purchase process. Interacts frequently with senior laboratory leadership to set priorities and implementation strategies.
- Works closely with vendors and PPD procurement to purchase and maintain equipment.
- Interacts with PPD customers and regulatory agencies during audits and visits.
- Oversees the development and implementation of laboratory systems and processes.
- Responsible for process improvement activities.
- Ensures client deliverables and needs are met.
Education and Experience:
· Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years) or equivalent and relevant combination of education, training, and experience.
· 5 years of management responsibility
· Proven leadership skills
Knowledge, Skills and Abilities:
· Thorough knowledge of GMP, GCP or GLP
· In-depth knowledge of clinical laboratory science, ICH guidelines, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, RandD, sample production and/or data processing
· Strong leadership skills including budgeting, forecasting and fiscal management
· Project and time management skills
· Excellent communication/interpersonal skills including presentation skills
· Demonstrated strategic planning skills
· In-depth global and cultural awareness
· Strong organizational agility and demonstrated drive for results
· Excellent coaching and mentoring skills
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.