As a critical member of our manufacturing operations, you would be responsible for the overall supervision, direction, and coordination of the Nanotechnology (NT) Formulation area and the surrounding controlled environmental area. You would be responsible for carrying out company objectives at the lowest cost consistent with quality requirements. This position supervises 7-21 direct reports accountable for compounding bulk product and equipment cleaning to meet delivered production schedules and compliance regulations. You would ensure that proper systems, equipment, material and resources are in place to meet production demands, and that products are manufactured to specification and in complete accordance with SOPs, DEA, OSHA and cGMP rules and regulations. You would also effectively develop resources to maintain production goals and efficiencies and recommends and implement Process Improvement Programs.
- Ensures adequate systems are in place to effectively manufacture Bulk product, and clean/store/prepare equipment and compounds.
- Ensures all area SOPs are reviewed/revised to encompass any changes in procedure and/or two-year review.
- Ensures adequate resources are available to clean and prepare equipment.
- Ensures all area personnel are current in their training requirements; Trains employees to area-specific Curricula and company policies and procedures. Ensures a safe work environment and that all personnel work in a safe manner.
- Schedules, verifies and troubleshoots the operation of the NT Formulation Areas.
- Ensures corrective actions for investigations and audit observations are completed in a timely manner. Ensures all documentation is correct and addresses errors effectively and expeditiously. Completes Batch Record review foe area.
- Works closely with HR on policy changes, interpretation and execution, hiring of new employees, employee disciplinary action, performance appraisals and performance management.
- Works with Technical Services/Maintenance to reduce downtime and improve equipment reliability; Assists with design of new systems/facilities related to the department.
- Works closely with Material Management and Quality regarding component problems and inventory maintenance.
- Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are met.
- Must have BS/BA in Science in a related discipline or equivalent.
- Must have a minimum of two to three years of pharmaceutical experience.
- Must have a minimum of five years supervisory experience in a highly regulated environment desired.
- Working knowledge of SOPs, DEA, OSHA, and cGMP rules and regulations.
REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES
- Must have demonstrated ability to manage multiple duties, assignments and projects.
- Must have strong oral and written communication skills.