Title: Associate Director US Industrial Operations
Location: Huntingdon Valley, PA
Salary: Excellent base salary plus bonus plus hyper-competitive medical benefits
The Client: JBAndrews is partnering with a global biotech leader in IVD
Summary
The Associate Director, US Industrial Operations has responsibility for the management and tactical leadership of Production and Quality Control (“QC”) functions to improve core processes that result in improved product availability, quality, and improved cost. The role will ensure that performance metrics are met by focusing on respect of demand planning, reduction of quality events, and improvement of the processes.
The Associate Director, US Industrial Operations reports to the Global Operations Manager, and will need to be in our Huntingdon Valley, PA US headquarters location full-time.
Essential Functions
Manage, lead and/or conduct all aspects of Manufacturing and Quality Control, including: process validations activities, process development, and yield improvements
Oversee and lead strategic execution and planning for products and processes
Management of the cost center of competence
Management of the routings to establish the correct Production and QC hours
Supervise their coordinators ensuring that deadlines are met and standards are upheld
Meet regularly with coordinators and set key indicators for evaluating performances
Enforce good manufacturing practices (GMP) compliance
Schedule production and QC activities
Ensure all safety procedures are followed and performance goals are met
Manage and lead continuous quality improvement of operation, and adopt quality improvement approaches
Hire, train, and evaluate manufacturing and quality control staff
Collaborate with research and product development teams to help assess feasibility, impact on processes and quality prior to large-scale production
Lead new product design transfer and introduction to manufacturing ensuring smooth transition of new product introduction and product changes
Work with internal and external stakeholders to develop operation strategies and plans
Manage and lead component procurement efforts to ensure stable supply chain and inventory levels
Routinely analyze manufacturing and production operations for efficiency
Fulfil business goals and report to executive management any manufacturing challenges and business needs
Write, review, revise, and approve SOPs
Establish goals for performance and report progress regularly to upper management
Monitor and trend data for continuous process improvement
Serve as a point person for internal and external GMP audits
Supervisory Responsibility
The position has three (3) direct reports in the following functional disciplines: Production/Manufacturing Supervisor, QC Supervisor, Process Improvement Manager.
Work Environment
This job operates in a professional office and production laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This is a combination of a sedentary office and production laboratory role. This would require the ability to stand/walk for long periods, engage in movement and lifting related to routine lab production, lift files, open filing cabinets, bend or stand on a stool or ladder as necessary.
Position Type/Expected Hours of Work
This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 7:00 am to 5:00 pm; however, this position may require longer hours, evening, and weekend work as necessary.
Travel
This position may require domestic and International travel (10% or less).
Required Education and Experience
B.S. or M.S. in molecular biology, biology, biochemistry, or other similar life science area
5+ years of proven pro-active management experience at a medical device or in-vitro diagnostics (“IVD”) manufacturer
Comprehensive understanding of GMP, GLP, GCP and GDP compliance
Excellent organizational skills, writing and oral communication skills and attention to detail
Ability to balance and prioritize multiple ongoing projects and tasks
Ability to work independently with minimal guidance
Ability to lead and inspire teams to reach goals and objectives
Ability to recognize and respect individual differences and abilities among team members
Proven ability to recognize critical situations and alert executive management
Proven ability to collaborate with other leaders to meet business goals and objectives
Proven ability to think critically, to manage challenges and decision making
Proven ability to communicate clearly and effectively to executive management, peers and teams
Desired Skills
Project Management experience to balance priorities and challenges, and budget management
Knowledge of applying statistical analysis for process control, sample plan definition, and design of experiments
Proficient with Microsoft products, incl. Word, Excel, Visio and Project
Experience with SAP
Preferred Education and Experience
Directly applicable experience in the IVD, medical device, or biotechnology industry
MBA degree
Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.