Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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

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.

Position summary

The Director, Manufacturing Sciences (Technical Operations) is a key leadership role at the Middletown, VA site with 500+ colleagues producing over 6 billion tests annually through custom, contract and OEM businesses for Hematology, Hemostasis, Clinical Chemistry, Immunoassay and Molecular.

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 goalsProvide 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 medical device 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 sites and global functions to drive successful outcomes.Proficiency in optimizing Customer Experience and a Dedication to Excellence.Ability to make timely decisions and knowing when to delegateAbility to manage multiple cross functional teams and provide governance on project teamsEffective written, interpersonal, and presentation skills.Ability to work on multiple projects simultaneouslyExpert knowledge of process development and/or manufacturing and regulatory guidelines: EU, USLeadership of people in multi-disciplinary technical and scientific teamsLeader in Operational ExcellenceAbility to travel up to 10%Excellent MS Office skills

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!