As a critical member of the Site Leadership Team, the Director of Ops Manufacturing is responsible for the operational and compliance performance necessary to drive growth and customer excellence. Working cross-functionally with Quality, Engineering, Research and Development, Supply Chain, HR and Finance, the Director will be responsible for organizing, managing and improving Operations activities in support of the development of new products or processes and the manufacture of products according to cGMPs and Right First Time in accordance with business unit objectives. The successful individual is responsible for building strong working relationships across the site and driving employee and customer engagement to next level and ultimately delivering safe and effective products to patients. The role is also responsible for building both a high performing team and high performing systems in order to drive and sustain business growth and to meet the demands.
Essential Functions:
Collaborate with the Senior Director of Operations and establish a strategic direction for manufacturing resources and activities, and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and providing educational opportunities for team members.
Share responsibility for short and long term resources and facility planning, and perform managerial duties as required, e.g. budgets, personnel performance appraisals, training, etc. Cross functional collaboration with Validation, Quality Assurance, quality control, technical services, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations. Partner with Facilities, Engineering groups to ensure effective standards are maintained for the maintenance and calibration of equipment/facilities to support manufacturing.
Provide leadership and support for continuing process improvement efforts for Manufacturing and Packaging. This shall include the initiation of Capital Projects, which benefit the line efficiency and/or productivity; along with project justification analysis, program preparation, project implementation, cost tracking, scheduling control and completion/closing of all projects on time and within budget.
Maintain the operational facility in the highest level of cGMP compliance per FDA and customer expectations.
Develop quality and business metrics for assessing productivity/profitability of manufacturing. Develop and manage the budget requirements for each fiscal year. Collaborate with Sr. Director, Operations organize the purchase of appropriate capital items as required for projects. Monitor and report progress of projects within agreed upon time lines, ensuring customer and Company objectives are met. Responsible for participating and representing all manufacturing operations in client audits as appropriate.
Ensure that all operations are compliant with Amneal EHS and Security Standards and OSHA and EPA requirements at all times. Ensure all company and site policies are adhered to and ensuring appropriate company disciplinary policies are followed consistently.
Additional Responsibilities:
Responds to calls during emergency situations related to safety, production break-down or facilities issues.
Participate in DEA and FDA audits.
Education:
Bachelors Degree (BA/BS) Pharmaceuticals manufacturing or related field - Required
Master Degree (MBA) Healthcare Management or related field - Preferred
Experience:
9 years or more Management experience in multiple complex dosage form manufacturing, i.e. liquid, nasal, topicals, transdermal, or medical device, equipment and production processes. Working knowledge of containment strategies for controlled substance, and highly potent compounds.
Skills:
Microsoft Software - Advanced
Experience in deviation and technical investigations - Advanced
Experience in logistics/planning of pharmaceutical liquid, nasal spray dose manufacturing operations is required. - Advanced
Working knowledge of containment strategies for controlled substance, highly potent compounds would be advantageous. - Advanced
Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor. - Advanced
Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization. - Advanced
Specialized Knowledge:
Excellent knowledge of FDA regulations in a pharmaceutical environment.
Experience in Equipment and Facility validation.
Occupational hazards and safety codes.
Principles and practices of personnel management and supervision.
OSHA standards.
Knowledge of liquid, nasal spray manufacturing and packaging equipment/troubleshooting process critical environmental control/ liquid, nasal spray processing.
