Summary of the Position: The primary responsibility for the Associate Director is to assist Vice President of Manufacturing Operations, direct and manage staff, processes, procedures and policies in effort to meet company goals and objectives, included but not limited to Safety, Quality, Compliance and Company Policies and Procedures.

Responsibilities include, but are not limited to directing, overseeing, planning, organizing, managing, controlling and evaluating the day to day operations of the department and area of responsibilities in order to optimize productivity, efficiency, and quality to meet the company goals and objectives.

The successful candidate will report to and work with the Vice President of Manufacturing Operations to develop short- and long-term goals for area of responsibilities.

Roles and Responsibilities:

Strategies, Policy and Budgets

• Assist in the development and implementation of manufacturing operations strategic plan, policies and procedures.
• Assist in preparing and overseeing the operations budget and expense management.
• Oversee all parts of manufacturing operations ensuring that they are carried out in a manner consistent with the operations goals and objectives, policies and procedures.

Leadership and People Development

• Develop overall knowledge and understanding of operational strategies in order to improve performance of each area.
• Assist in the supervision and coordination of operational and administrative activities specific to Manufacturing, Packaging and Facilities Management.
• Assist, in directing all functions related to the purchase of equipment, supplies and services for each department for the purpose of ensuring compliance with State and Federal regulations and general accounting procedures.
• Identify, recommend and implement goals and objectives consistent with company's mission. Provide leadership, motivation, and direction to the operations team.
• Provide regular communication and feedback to the operations team
• Develop a team-orientated manufacturing environment, dedicated and committed to quality and customer satisfaction.
• Communicate, on a daily basis, with the VP of Manufacturing and as needed, with the Maintenance, Sales, Marketing, QC, QA, HR and Warehouse personnel, and any other internal customers to accurately plan and manage the short-range schedule.
• Hire, lead, manage, coach, develop, promote and discipline employees.
• Assist in directing and managing all processes and procedures in respective department and areas of responsibilities.
• Evaluate, monitor and report employee, products, processes and equipment behaviors and performances.
• Make recommendations and provide assistance to Vice President of Manufacturing Operations related to all aspects of Manufacturing Operations, in proactive and timely matter, communicating in written and verbal form.
• Coach, promote and enforce compliance to cGMP's, SOP's, Safety Procedures and Company Policies.
• Listen, communicate and follow up with direct reports and all other employees of the company.
• Maintain process without deficiencies and deviations.
• Develop plans for continues improvements related to area of immediate responsibilities and analyze and present data related to these efforts.
• Train and record training of the direct reports and staff indirectly reporting to this position.
• Promote positive relationships and harmony within the team and company.
• Scheduling and participating in day-to-day activities in the Production/Packaging Department to ensure daily production goals are met.
• Developing production/packaging guidelines and SOPs.
• When necessary, participate in regulatory external and internal audits.
• Monitoring the calibration/validation programs for compliance; reviewing and approving associated documentation.
• Develop and implement plans related to cost savings efforts, report progress and meet goals.
• Coordinate efforts related to area of responsibilities with vendors and contractors as necessary.
• Ensuring all safety methods are followed during daily production/packaging.
• Must be able to effectively communicate with other departments and function within a team environment.
• Performing other assigned duties that may be required to meet company goals and objectives.
• Effectively use ERP System and systems related to monitoring, evaluation and improvement of productivity, efficiency and cost savings.
• Support product/process technical transfer efforts
• Maintain and improve 5S System.
• Develop, measure, report and improve KPI such as product yields etc.

• Build culture of safety first in compliance with Environmental, Health and Safety through all manufacturing associates and staff.
• Support development and communication of Job Hazard Analysis

Plant Production, Environmental Services, Maintenance and Engineering

• Ensure that the standard operating procedures (SOP), GMP's and safety procedures and standards are adhered to on a daily basis.
• Assist in establishing, maintaining and improving productivity measures for each process area and help develop and review production and cost variance reports to resolve operational, manufacturing and maintenance problems to ensure minimal cost and prevent operational delays.
• Ensure standards for product quality, equipment and operator performance are maintained and that cost-effective technology is used to maximize production

Process and Product Improvement

• Work with operations to introduce process improvement initiatives to increase productivity and continually review all aspects of operations in an effort to control and reduce costs and improve efficiency.
• Investigate feasibility of new products and product improvements.
• Participate in product development efforts and support the same.
• Communicate and offer suggestions to challenges related to new products.
• Collect, analyze and interpret processing data and offer continues improvements ideas.
• Through regular visits to the manufacturing floor, assist staff with all challenges and lead/support the resolution of same.
• Manage daily, weekly and monthly meetings as required.

Minimum Requirements: Good written, interpersonal and oral communication skills a must. Strong skills in problem solving, time management and cost savings required. Ability to work collaboratively with internal and external team. Must be proficient in MS Office Suite. Must be able to work extended hours and as necessary on Fridays and Saturdays.

Education and Experience: Bachelor's degree in Business Administration preferable with a minimum of 10 years in a regulated industry or equivalent combination of experience, training and education may be substituted. Process Engineering experience in a GMP production or Pharmaceutical environment preferred

Management Responsibilities: Yes