Website Keystone Pharmaceutical and Research
Operations Manager (Gel Operations)
Essential Job Functions
- The Operations Manager will direct, plan and oversee production operations related to KR&P UV curable products and assist in the facilitation of order processing.
- Interact as required in the determination of manufacturing process economics and associated budget plans.
- The Operations Manager will assist in the direction of short and long term strategic planning for KR&P.
- Assist / direct the coordination of ISO and cGMP compliance of KR&P for manufacturing operations.
- Hire, train, direct and supervise KRP manufacturing personnel; exempt and non-exempt.
- Assist in the direction of various internal audits related to quality, safety and overall productivity. Ensure adherence to ISO and regulatory standards as required. Promote root cause / corrective / preventive actions and the drive for continuous improvements.
- Assist / direct the preparation of documents relating to Standard Operating Procedures, batch cards and other documents, reports and records, as necessary.
- Assist / direct the review/approval/verification of product or process requirements and the associated documentation.
- Assist in the processes of addressing the proper hazardous and waste material handling related to the KRP processes.
- Assist / direct in the assessment of identifying / specifying necessary equipment and facility upgrades. Perform financial analysis of projects/upgrades as may be required.
- Routinely work with management and production personnel to ensure a smooth flow of finish products to meet customer expectations.
- The Operations Manager is responsible for recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling and disciplining employees; communicating job expectations; planning monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions, enforcing policies and procedures.
- Responsible for performance evaluations of Manufacturing team members and for providing training and development opportunities, including management training, for those inside the department.
- Ability to lead, motivate and develop a team –
- Ability to effectively communicate with employees – engage and motivate, enhancing performance
- Assist in direction of the overall monthly production planning and scheduling.
- Promoting safety programs, participation in programs
- Addressing safety and health issues for self and employees
- Manufacturing operations management experience
- Process Engineering experience:
- Development, scale-up and plant introduction of associated processes.
- Manufacturing operational troubleshooting techniques.
- Waste handling experience
- Hazardous response experience/knowledge
- OSHA safety experience
- Experience related to the interaction and development of quality assurance / quality control systems
- Excellent interpersonal communication skills and associated business acumen
- Personnel management experience and team building concepts
- Ability to direct, mentor, coach, supervise, and delegate work as required
- Strong writing and organizational skills
- knowledge of information systems and interaction Demonstrated knowledgeable of plant management skills associated with batch process chemistries
- Demonstrated knowledge of FDA, cGMP, OSHA, EPA standards required
- Demonstrated knowledge of UV Curable and polymerization chemistries
- Demonstrated for planning / scheduling
- Facility management experience
- ERP & MRP experience
- UV Curable chemistry experience
- 6 sigma training
- 5S training
- Lean manufacturing training & implementation
- Bachelor’s Degree with association in Chemistry, Chemical Engineering or Industrial Engineering, along with Business Management experience; MBA recommended.
Physical Demands and Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Physical Demands: Employee is required to walk; sit; occasionally use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; stoop; bend; and kneel. The employee may occasionally life/move up to 40 pounds with or without assistance.
- Work Environment: This position requires one to primarily work in an office environment and occasionally manufacturing environment. There may be some noise, heat, cold, dust, dirt and fumes. Employee may occasionally work near moving mechanical equipment and chemicals. Employee may occasionally be exposed to varying temperatures.