Operations Manager - Manufacturing and Packaging

Job Description

Job Description

Job Summary -

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.

Chestnut Ridge Operations 1st & 2nd shift

Key Accountabilities

Accountability & Responsibilities

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.

Education & Experience

• 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.

Knowledge

• 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.

Skills & Abilities

• 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.

Physical Requirements

• 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.