Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

The Senior Director Operations is part of the division global operations leadership team and Niche Diagnostics business unit (NDX) within our Clinical Diagnostics Division (CDD). Serving both direct and Original Equipment Manufacturer (OEM) customers, NDX provides an innovative portfolio which enables our customers to 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.

POSITION SUMMARY

The Senior 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, delivering perfect quality products to our customer on-time at lowest cost and inventory. This position also operates as the Fremont site leader reporting into division VP, Operations for CDD with a dotted line reporting to NDX’s VP/GM. It will lead Operations teams across 3 value streams (toxicology, controls and specialty) as well as facilities and manufacturing services.

Key Responsibilities:

· Direct the business unit’s product line operations (collaborating with the Director, Supply Chain) 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, quality controls, facilities, and organizational objectives that support the annual operation plan

· Ensure production goals are achieved, and 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

· 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

· 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, manufacturing cycle time and total cost by utilizing the PPI Business System.

· Develop and lead high-performing teams to ensure operating effectiveness; leverage team capabilities that drive ownership and accountability and work to break down barriers that impede business success

· Collaborate with senior leaders of major customers and internal stakeholders to provide outstanding service in line with their expectations

· Lead with composure and a focus to detail, results orientation and profitability mindset along with the ability to operate successfully in a fast-paced environment

Qualifications

Education:

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

• 15+ years’ of experience in Operations, R&D, Quality or Engineering with expertise in managing and developing staff in a manufacturing operations environment is required, preferably with exposure to high volume, high mix, reagent, antibody and controls immunoassay production

Knowledge, Skills and Abilities:
• Significant experience in running manufacturing organizations and site leadership; multi-site experience preferred

• Advanced training in continuous improvement methodologies (Six Sigma, Lean)
• Demonstrated P&L management and operational excellence experience at scale
• Strong working knowledge of cGMP, FDA, and other relevant quality/regulatory requirements

· Exposure to global operations including but not limited to 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

· 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
• Strong business acumen and analytical capabilities
• Effective communication and influence skills across all organizational levels
• Ability to implement change and deliver results in matrix environments
• Experience with ERP systems and manufacturing technologies
• Strong project management capabilities
• Strategic mindset with ability to balance short and long-term priorities
• Experience in customer/client relationship management
• Strong problem-solving and decision-making abilities
• Change management and transformation experience
• Cross-functional collaboration and influence skills
• Financial planning and budget management expertise

• Ability to travel 5-10% as required

Compensation and Benefits

The salary range estimated for this position based in California is $210,200.00–$300,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards