Manager, Operations
- Chestnut Ridge, NY
- $110,000-160,000 per year
- Permanent
- Full-time
- The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product.
- Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements.
- Mentor staff and set goals and objectives for the production personnel.
- Manufacturing Operations Management
- Assure the accurate execution of cGMP/DEA documentation relative to manufacturing and packaging activities.
- Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.
- Assure the accurate packaging of drug product in approved primary packaging components without deviation
- Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.
- Assure the accurate assessment of component inventory and reconciliation.
- Assure staff training requirements are established and complete prior to the performance of process or procedure.
- Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.
- Establish performance Goals and Objectives based on facility needs and High Corporate Standards.
- Complete routine performance evaluations of staff, and recommend growth opportunities.
- Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.
- Monitor the general safety of staff and assure safe work practices are followed by all site personnel.
- Undergraduate Degree in Pharmacy, Engineering, or equivalent in training and experience.
- 10 years’ experience in a pharmaceutical manufacturing environment.
- Prior cGMP experience in a pharmaceutical production environment is necessary. 3-5 years’ previous supervisory experience required.
- Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Knowledge of workplace health and safety requirements for applicable hazardous substances.
- Must be able to demonstrate a high degree of understanding in the cGMP practices.
- Must be able to demonstrate a high degree of understanding in the controlled drug substance regulations.
- Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Demonstrate knowledge of the current good manufacturing practices.
- Ability to convey information clearly and concisely to both individuals and groups.
- Ability to troubleshoot manufacturing processes, write investigations and complete documentation.
- Ensure adequate staffing and efficient workflow and provide reports and data on manufacturing activity.
- This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.
- Ability to don personal protective equipment, if necessary. Able to walk the production floor.
- This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.
- Ability to don personal protective equipment, if necessary.
- Able to walk the production floor.