Senior Director, Operations-Niche Diagnostics

Company: Thermo Fisher Scientific
Location: Fremont, CA 94536

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When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information
The Sr. Director of Operations is part of the Niche Diagnostics business unit (NDX) within our Clinical Diagnostics Division. NDX is the leader in Drugs of Abuse Testing. Serving both direct and Original Equipment Manufacturer (OEM) customers, NDX provides an innovative portfolio which enables our customers to accelerate innovation and enhance productivity. Customers worldwide trust our products and services to help them accelerate innovation and enhance productivity. With an extensive portfolio of over 3,200 innovative products, NDX specializes in Drugs of Abuse Testing, Drug Monitoring, Molecular Controls, IVD Controls, Technologies & Companion Diagnostics. Through our rigorous assay development and manufacturing processes, we are well-known for our high performing assays.

This position will be based at our facility in Fremont, CA, and will have a travel expectation of approximately 10-15%, including some global.

How will you make an impact?
The Sr. Director, Operations interacts with all areas and levels of the organization, using a multi-disciplinary approach to problem solving, and works to motivate team members toward the common goal, deliver perfect quality products to our customer on-time at lowest cost and inventory.

What will you do?

  • Direct the business unit’s product line operations to achieve on time delivery, demand based capacity throughput, safety, quality, cost and continuous improvement through lean leadership.
  • Review and approve the implementation of operations, supply chain, and organizational objectives that support the annual operation plan.
  • Ensure production goals are achieved and assure production and laboratory standards are in compliance with all GMP, ISO, FDA, OSHA and other company manufacturing and safety guidelines. Ensures quality systems are effectively maintained to achieve strong levels of GMP/ISO/FDA/OSHA compliance.
  • Establish and implement regional supply chain strategies to support evolving business requirements and global supply chain strategies in partnership with divisional, regional and external stakeholders.
  • Responsible for meeting financial targets, key measurements and benchmarks including productivity, operating income, revenue, margins, inventory, and growth.
  • Develop specific short-term and long-term goals and plans with supporting budget requests and financial estimates.
  • Balance supply and demand to achieve the optimal balance between worldwide inventory levels, plant operating efficiency and effectiveness, and on time delivery for the products served by the Niche Diagnostics Center of Excellence.
  • Responsible for ongoing management of Sales, Inventory and Operation Planning (SIOP) and for minimizing excess and obsolescence
  • Develop and leverage close relationships with the regional commercial leadership to ensure tight alignment with evolving customer requirements, including available to promise, delivery and value-added services, documentation requirements, etc.
  • Provide visionary leadership to accomplish continuous improvement in quality, customer service, manufacturing cycle time and total cost by advocating and driving the PPI Business System. Drive strategies to decrease costs at least 3% per year across the organization.
  • Build strong team in operations and supply chain organization through organic development and acquisition
  • Require routine, disciplined operational reviews that cascade through the organization to the warehouse floor, enabling rapid escalation of performance issues and objective evidence of strong performance to be rewarded.
  • Collaborate with senior leaders of major customers and internal stakeholders to provide outstanding service in line with their expectations.

How will you get here?
Education

  • B.S. Degree in Chemistry, Industrial Engineering, or other scientific/technical discipline required.
  • Advanced degree such as MBA or Masters preferred.

Experience

  • 10+ years’ of experience in Operations, R&D, or Engineering with expertise in managing and developing staff in a manufacturing and/or distribution operations environment is required, preferably with exposure to high volume, high mix, reagent, antibody and controls immunoassay production in an inter-disciplinary manufacturing environment.
  • Extensive previous experience in a diagnostic manufacturing environment with thorough knowledge of a variety of laboratory chemicals, potentially hazardous chemicals, human source materials, and reagent manufacturing activities.
  • Exceptional supply chain optimization expertise and project management experience
  • Experience in implementing or working with an effective continuous improvement i.e. LEAN, Six Sigma, etc.
  • Experience in developing and driving a site validation program for both equipment and process validations.
  • Practical understanding and experience with IT systems (ERP, MES, WMS etc.)
  • Exposure to global operations including but not limited to 3PL, international distribution, including packaging labeling, export documentation, duties, and regulatory approvals.
  • Experience in attracting, retaining and developing others through personalized development plans with a track record of developing future leaders.

Knowledge, Skills, Abilities

  • Advanced understanding and ability to adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics
  • Technical skills in manufacturing techniques, FDA, GMP, ISO 13485 compliance, process improvement and process development.
  • Broad knowledge of P&L, Balance Sheet, NPV/ROI, and cost accounting principles.
  • A strong balance of analytical skills and action orientation to drive sustaining results with intensity, at times demonstrating the confidence, conviction and collaboration to innovate new strategies and methodologies.
  • Track record of achieving results and proven ability to clearly identify and communicate a cogent vision; effectively manage through ambiguity and uncertainty, take appropriate risks and make sound and timely decisions.
  • Excellent communication, executive presentation, and leadership skills with a collaborative approach to problem solving
  • Collaboration skills – Able to effectively collaborate with peers in other functions and with colleagues in other businesses or divisions
  • Superior organizational skills with ability to multi-task and balance complex and routine work activities.
  • Ability to lead, motivate and influence others. Highly talented at team building, coaching and mentoring with a passion for inspiring others at all levels of the organization.
  • Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com