Job Description

Job Description: Director, (Manufacturing) Technical Operations

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!

This position is part of the Clinical Diagnostics Division (CDD) which provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the IVD industry for over 40 years. CDD delivers products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening, advanced laboratory instrumentation and high-throughput laboratory automation equipment for use in a variety of laboratory settings.

The Director, Manufacturing Technical Operations is a key leadership role at the Middletown, VA site with 500+ colleagues producing over 10 billion tests annually through custom, contract and OEM businesses for Hematology, Hemostasis, Clinical Chemistry, Immunoassay and Molecular.

Visit the site: Middletown Matters - YouTube

Listen to one of our colleagues: https://www.youtube.com/watch?v=klAVrUJqfVc

Find out more about Thermo Fisher: https://www.youtube.com/watch?v=zPVv85C6XSE

How you will make an impact:

The Director, Manufacturing Technical Operations leads the site technical teams providing strategic direction in the areas of formulation development, manufacturing processes and technology, process improvement, quality performance and improvement.

• Lead, develop and inspire the team to meet site and organizational goals
• Provide leadership to the technical team responsible for transfer of new products, ensuring facility fit and appropriate processes and procedures are established through commercialization/life cycle support.
• Identify and lead initiatives that optimize business and manufacturing processes.
• Serve as the subject matter expert in technical meetings supporting customer interactions and resolving product issues.
• Directly support site manufacturing operations by driving effective alignment and partnership for manufacturing process optimization and day-to-day troubleshooting support for manufacturing operations.
• Facilitate resolution of technical issues within the manufacturing operations in collaboration with Quality including support of root cause and CAPA identification, and lot release, conduct and write NCR investigations and drive CAPA implementation.
• Own the site Design Master Files for all products.
• Provide technical expertise for technical investigation and technical reports, and process related issues during production.
• Coordinate and plan team’s project delivery and activities, meeting the financial needs of the company while balancing the needs of customers and end users.
• Develop and implement programs to drive operational excellence towards right first time and on-time delivery.
• Maintains proficient knowledge of FDA requirements and industry best practices for IVDR.

Education:

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science. Masters or PhD preferred.

Experience:

• 10 years experience in the pharmaceutical, or IVD/IVDR contact manufacturing industry with direct technical experience. 8 years experience in a management role.

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

• Ability to drive safety, quality, functional, technical and operational excellence.
• Ability to inspire and foster innovation, transparency, and team effectiveness.
• Ability to lead and drive change in a complex manufacturing environment.
• Ability to collaborate across multiple site and global functions to meet drive successful outcomes.
• Ability to drive Customer Experience and a Commitment to Excellence.
• Ability to make timely decisions and knowing when to delegate
• Ability to manage multiple cross functional teams and provide governance on project teams
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously
• Expert knowledge of process development and/or manufacturing
• Leadership of people in multi-disciplinary technical and scientific teams
• Expert knowledge of regulatory guidelines: EU, US
• Leader in Operational Excellence
• Ability to travel up to 10%
• Excellent MS Office skills