Summary: Responsible for leading the Parenteral manufacturing process assuring compliance with applicable policies, regulations, and procedures. Leads all of the lyophilization activities pertaining to the Manati Sterile Operations (Par Lyo and Parenterals Vials (PVA). Meets budget objectives and productivity or process / line defects targets. Drive area projects to completion. Keep work pace and plan work schedules, set priorities with urgency and meet deadlines within a complex, rapidly changing environment. The incumbent must comply with Corporate and HR Policies, FDA, GMP, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Responsibilities: 1. Oversees resources availability (material, equipment, personnel – regular and lease workers) necessary to meet and comply with timely production plan. 2. Verifies adherence to procedures and controls and provides corrective feedback during operations by frequent monitoring of production activities 3. Performs systematic walkthroughs of operation floors. 4. Establishes corrective actions plan to eliminate process deviations and documentation errors. 5. Provides support efforts: to release lots on hold and conducting thorough reviews of investigation reports, with the Annual Requalification Program by assuring on time execution of requalification activities and with the Environmental Monitoring Program by assuring on time samples/data collection and delivery 6. Defines job skills requirement for manufacturing positions which includes back-up operators for critical positions and supports the training program design assuring adherence to training plan including employee certification and re-certification program. 7. Prepares and/or approves necessary SOP's and forms to be in full compliance with cGMP's and reflect manufacturing processes. 8. Complies and ensures the compliance of Company Environmental, Health, and Safety goals programs and objectives. 9. Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan execution. 10. Identifies opportunities to improve process performance and/or safety requirements and supports Continuous Improvement initiatives in the daily operation activities. 11. Generates and approves changes as established in Change Control procedure. 12. Assists in preparing manufacturing budget, and establishes effective cost control programs to meet budget targets and objectives per company strategic plan. 13. Prepares on time performance reviews, manages employee disciplinary actions as needed and monitors attendance trends enforcing applicable Company policies and procedures. 14. Performs as the back-up of area Manager when is required. 15. Supports Maintenance Programs by assuring on time execution of applicable preventive and corrective maintenance plans. Knowledge/Skill: Bachelor Degree in Science, Administration, or Engineering Five (5) years experience in Lyophilization, Compounding, Sterilization and Aseptic Filling processes, and product transfer validation in a Pharmaceutical manufacturing environment, Three (3) years of solid supervisory experience, or leading multidisciplinary teams ( disciplinary actions, performance appraisals, development of succession plans, etc). Ability to facilitate continuous innovation initiatives, foster team building and simplify processes. Ability to maintain good employee relations and to handle grievances and complaints. Self-starter with strong leadership characteristics, analytical, administrative and people skills. Ability to communicate and work effectively in a team oriented environment. Knowledge of cGMPs, safety and environmental regulations, human resources and labor laws. Personal computer skills, knowledge in Excel, Word, PowerPoint, Internet. Fully bilingual oral and written (Spanish/English). Technical writing skills. Sense of urgency and business needs. Capability to use protective gowning Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary. SDL2017
