Job Summary

Overall responsibilities include Operations Management for Aseptic and Dermatologic product lines, as well as oversight of Plant Services, Manufacturing & Validation Engineering, and Materials/warehousing. Overall responsibility for the inspection, maintenance, repair and servicing of plant equipment, buildings and facilities.

Area Of Responsibility

• Coordinate production, Materials/warehousing, plant engineering and related support functions to maximize productivity, quality and profitability while minimizing cost and working within an established budget
• Responsible for identifying staffing and needs for training, developing and motivating subordinates in materials management, plant operations, facility maintenance and all system, process and equipment validations
• Prioritize production schedules based on inventory requirements, new product introduction, equipment efficiency and material supply
• Responsible for the inspection, maintenance, repair and servicing of plant equipment, buildings and facilities, ensuring building codes and safety standards are maintained
• Assure maintenance of materials, parts and specialized tools to prevent work stoppage; and, through subordinates, assure maintenance projects by employees or private contractors conform to specifications and contracts
• Interface with other Site Leaders to formulate and integrate manufacturing objectives to achieve overall company goals
• Hire, train and evaluate performance of subordinate personnel
• Achieve continuous improvement in final product yields for manufactured products and promote quality improvement activities
• Responsible for activities involved with building security
• Ensure that personnel are trained, per cGMP regulations, for all aspects of the jobs they are performing
• Other duties as assigned

Work Conditions:

• Office
• Shop/shipping areas
• Controlled areas

Physical Requirements:

• Sit, stand, walk, use hands and fingers to handle or feel, reach with hands and arms
• Climb and balance, stoop, kneel, crouch or crawl
• Close, distance and color vision; depth perception, ability to focus
• Talk and hear, smell and taste
• Operates computer/office machines
• Operates process equipment (i.e.: autoclaves, dry heat ovens, auto filling lines, isolators, etc.)
• Wears proper gowning and safety glasses

Travel Estimate

Up to 10%, including international travel

Education and Job Qualification

• B.S. in Engineering or other science required; Master’s degree preferred
• Minimum 10+ years in pharmaceutical manufacturing or compliance, with 5-8 years management experience

Experience

• Direct experience and training on industry standards for aseptic manufacturing, engineering and validation requirements
• Strong team management skills who exhibits a high level of initiative and self-motivation
• Strong computer skills
• Ability to plan, prioritize and organize diversified workload
• Excellent verbal, written and interpersonal communication skills
• Strong knowledge of FDA cGMP, SOP’s and ICH, and EU standards
• Detail-oriented and strong record keeping skills