Director Production

Purpose & Scope:

Provide managerial leadership in a team-based environment for all personnel involved in production of APT pharmaceutical products. This position will be responsible for all operational aspects of APT products. This will involve development and maintenance of required procedures, staffing, warehousing, product manufacturing, and compliance with governmental regulations.

Essential Job Responsibilities:

• Direct the execution of the pharmaceutical production plan for the site, communicating the requirements of each customer and coordinating the timely production of in-specification products to support various customers’ needs.
• Promote safe practices and hazard awareness to provide a safe working environment.
• Direct payroll and operating costs within budget, including researching, forecasting, planning, and budgeting for any future changes to manufacturing operations, in order to evolve with changing business requirements. Evaluate, select, and purchase system equipment. Manage multiple departmental budgets in meeting financial objectives. Manage plant performance, manufacturing, quality, and sanitation costs.
• Direct the development and training of the operations department including Area Managers and Manufacturing Technicians.
• Oversee performance appraisals and pay reviews of Manufacturing Technicians from multiple manufacturing departments, with focus on fair ratings application and salary rankings by Area Managers.
• Develop, direct, and oversee procedures required to meet quality, cost, and delivery goals of APT pharmaceutical operations. These goals include on-time deliveries, budget conformance, regulatory compliance, and safety.
• Apply the principles of Kaizen to ongoing pharmaceutical operations.
• Support technology transfers, validations, plant trials, and other customer requests through the management of available technical resources, labor, and planning resources.
• Meet the requirements of all applicable regulatory agencies. Responsible for implementing policies and procedures and assuring employees understand and comply with all HS&E procedures, OSHA requirements, cGMPs, SOPs, FDA, DEA, PMDA, EMA, and ISO regulations by providing oversight of staff training, task execution, and documentation.

Quantitative Dimensions:

• Works cross-functionally with all local departments and globally when needed.
• Manages 5-10 capital projects each year.
• Responsible for an annual budget of approximately $5.1 million.
• Ensures quality products are supplied in a timely manner, feeding global demand.

Organizational Context:

• Reports to Vice President and Site Director
• Supervises multiple Area Managers and an operations department of 50+ Manufacturing Technicians.

Qualifications:

Required

• Minimum 10 years’ experience in pharmaceutical production management, or 8 years with aMA/MS.
• BS in a technical discipline and experience that demonstrates competencies required for this position.
• Must be able to read, write, and understand the English language
• Current demonstrated experience and a working knowledge of FDA and OSHA regulatory requirements.
• Interpersonal skills and management experience that provides a basis to support the team-based system.
• Demonstrated leadership skills for directing large cross-functional groups.
• Must be able to lift, push, pull, and rotate a variety of containers weighing up to 50 lbs. Must be able to perform same function with assistance for items weighing over 50 lbs.
• Must be able to stoop, bend, twist, and stand for long periods of time.
• Must be able to climb as many as three stories of stairs repeatedly during a shift of work.
• Must be able to climb ladders and perform work elevated above ground level.
• Must perform work while wearing required personal protective equipment, i.e., respirators, eye protection, rubber gloves, arm protectors, safety shoes, and hearing protection where needed.