Job Openings

Manager, Production

MANAGER, PRODUCTION
Raleigh, North Carolina

SUMMARY
Responsible for the management of all manufacturing activities for the sterile filling business unit. The direct reporting staff includes the following: Compounding Supervisor, Fill/Finish/Lyophilization Supervisor, Component Preparation Supervisor and all activities in this business unit are overseen by this position.

RESPONSIBILITIES

• Directly responsible for managing supervisors and coordinating activities for the business unit.
• Responsible for ensuring and enforcing compliance with cGMPs, corporate and site-specific policies and procedures.
• Will serve as the representative for the business unit to all internal support groups and aid with external customers.
• Responsible for maintaining and reporting metrics to evaluate the performance of the business unit. 
• Responsible for professional development and mentoring of direct reports.
• Responsible for the succession planning and in-depth cross-functional training of all members of the business unit.
• Directly responsible for production schedule adherence.
• Directly responsible for the operational and coordination of all processing equipment assigned to the business unit.
• Responsible for all safety incidents and quality deviations that occur and responsible for the thorough investigation and timely reporting of such.
• Must become fluent in all functional areas of responsibility in the business unit.
• Must share resources with other business units as needed and when available.
• Must develop and manage budget and performance objectives/evaluations.
• Must perform batch records review/approval. Participate in technical transfer and validation activities affecting the department.
• Interact with clients and regulatory agents during audits.

REQUIREMENTS

• B.S. degree in scientific field or business is required.
• Minimum 10 years of directly applicable experience in the pharmaceutical industry, including 5 years of management experience in an aseptic manufacturing environment.
• Minimum 5 years aseptic processing and lyophilization experience.
• Must have proven leadership skills, technical skills, team building skills and experience managing production employees on all shifts.

EOE/AA M/F/D/V