This position provides leadership to the manufacturing department engaged in the production of both clinical and commercial drug products. The Associate Director ensures that the production department is adequately staffed with properly trained, knowledgeable employees who perform their duties according to approved Manufacturing directions, Standard Operating Procedures, company guidelines for safety and environmental compliance, as well as current European and US Good Manufacturing Practices. The Associate Director is responsible for assuring production schedules are met in an efficient and timely manner.
· Provide leadership to the manufacturing of quality pharmaceutical drug products to support both commercial and clinical needs of the manufacturing facility.
· Communicate effectively and establish productive working relationships with Materials Mgmt, Quality Control & Quality Assurance, and Environmental Health and Safety departments.
· Works on complex problems involving intangible variables.
· Provides guidance/troubleshooting abilities on manufacturing issues.
· Provide leadership and management for direct reports: Production Managers, Process Technologists, Commercial/Clinical Team Leaders, and Manufacturing Compliance Specialist.
· Participate in routine meetings: company Tactical Teams, Materials, plant site quality, production etc.
· Manage the production dept. in the areas of quality, compliance, safety, housekeeping, efficiency, planning, customer service, training and employee development
· Review and approve GMP documents for use in production and assure that completed documents are accurate and complete prior to forwarding to Quality Assurance for archiving
· Approve protocols, coordinate the validation activities related to production equipment and facilities, and approve final validation reports.
The qualified candidate must have a Bachelor degree in a Science or Engineering Discipline (post-graduate degree preferred).
Minimum of 10 years progressive management experience in pharmaceuticals manufacturing. Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution). Thorough knowledge of cGMPs.