Associate Director, Operations - Boston Area Pharma

Associate Director, Operations

My client, a large generic pharmaceutical company is based in Norther Central New Jersey, rapidly building their brand presence. They manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non- warehousing chain drugstores as well as managed care providers.

Their goal is to continue to develop and market quality products that bring value to their customers and ultimately the patient. Current manufacturing capabilities allow them to develop products across most therapeutic categories.

They believe their people are an invaluable asset. Their culturally diverse workforce is one of their biggest strengths, along with the rich experience they bring across varied skillsets. They are proud that their global workforce is bound by their common values.

Currently seeking an Associate Director, Operations for this manufacturing site.

YOU:

• Must have aseptic, fill/finish experience for commercial pharma batches
• Strong knowledge of FDA, cGMP, SOPs and ICH, and EU standards
• Effective, team-oriented leader
• Experience training on industry standards for aseptic manufacturing, engineering and validation requirements
• Ability to plan, prioritize and organize diversified workload
• Must be authorized to work in the US without sponsorship
• This is an onsite role, Boston Area

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.

RESPONSIBILITIES:

• 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

REQUIREMENTS:

• 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
• 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
• Up to 10% travel, including international travel