ALBANY MOLECULAR RESEARCH, INC
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Senior Manager Operations in Albuquerque, NM at AMRI
at ALBANY MOLECULAR RESEARCH, INC
Job Status: Full Time
Job Reference #: J3N43H6SQJZN43X281M
Categories: Management - Mid-Level (Manager, Director)
Senior Manager of Operations
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Summary Production Operations is responsible for the preparation of all components and equipment used in the sterile filling process, conducting the sterile filling processes, the decontamination of sterile filling equipment, and the sanitation and preparation of the processing facilities. Production Operations accounts for 70% of the site staff and spend.
This position is responsible for approximately 90% of the total site revenue, approximately 70% of the site spend, all customer interactions for their specific product line, equipment and assets, as well as all day-to-day and strategic manufacturing operations for a 24x7 operation. This position will be part of the extended site leadership team.
The Director is responsible for the tactical and strategic management of manufacturing operations and personnel. This encompasses planning, coordinating, and supervising manufacturing in accordance with delivery dates, customer specifications, established quality standards and meeting all FDA and international regulatory and customer requirements. The Director is responsible for all Primary Manufacturing Operations at Albuquerque including compounding, Wash & Prep, Glass Prep, short-range production scheduling, sanitation, sterilization, and sterile filling. The Director supports the Quality Assurance Product Specialists and Customer Service Representatives for direct customer contact.
The Director is responsible for managing a team of approximately 145 hourly technicians, 5 shift managers, 5 supervisors, 3 Senior Specialists and 3 supervisors in training. Also responsible for the training dept. and Sterile University. The position is responsible for all aspects of producing product for the three lines in the facility. The Director is responsible for developing and implementing metrics to evaluate the performance of the manufacturing operations. The Director is responsible for the training and development of the aseptic filling team including management, hourly and supervisory personnel. The Director is also responsible for integration of 6-Sigma and LEAN manufacturing into the organization.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Performs the usual duties of a Director such as developing and managing budget and performance objectives, scheduling, hiring, timecards, performance evaluation, termination, etc.
- Provides oversight of the employees and functions of the Production Operations areas in the preparation of equipment and components to be used in the filling process and the completion of the sterile filling process.
- Reviews and approves discrepancy reports to effect release of product.
- Leads, attends and participates in meetings that affect release of product and schedule planning.
- Works on projects to analyze and improve manufacturing process; writing SOP’s and documenting project.
- Ensures proper training of staff and appropriate records of training have been kept.
- Directly and through staff (three Shift managers, six supervisors and 3 supervisors in training) ensure cleanliness of assigned areas, sanitation of clean rooms, sterilization of filling equipment, the wash and prep of filling equipment, the preparation of vials and ampoules, and the completion of the sterile filling process.
- Directly and through staff understands and implements safety procedures and cGMP.
- Responsible for the training and development of the supervisory staff.
- Directly and through staff, responsible for customer interactions for scheduling, forecasting, issue resolution.