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Associate Director, Operations

Billerica, MA 01821

Posted: 06/15/2023 Employment Type: Direct Hire/Perm Job Category: Scientific Job Number: 566133 Is job remote?: No Country: United States

Job Description

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

Pay Rate Range: $175-200k. Salary will be commensurate with experience.
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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