Director, Manufacturing Sciences at Thermo Fisher Scientific

Middletown, Virginia, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Diagnostics, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science. Masters or PhD preferred
10 years experience in the medical device or IVD/IVDR contract 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 of FDA requirements and industry best practices for IVDR
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

Responsibilities

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

Skills

Key technologies and capabilities for this role

GMPManufacturing ProcessesProcess ImprovementFormulation DevelopmentTechnology TransferQuality ControlTechnical OperationsHematologyHemostasisClinical ChemistryImmunoassayMolecular Diagnostics

Questions & Answers

Common questions about this position

What is the work location for this position?

The position is based at the Middletown, VA site.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the key responsibilities of the Director, Manufacturing Sciences role?

The role involves leading technical teams in formulation development, manufacturing processes, process improvement, quality performance, new product transfers, process optimization, troubleshooting, CAPA implementation, and owning site Design Master Files.

What is the team size and focus at the Middletown site?

The site has 500+ colleagues producing over 6 billion tests annually through custom, contract, and OEM businesses for Hematology, Hemostasis, Clinical Chemistry, Immunoassay, and Molecular.

What makes a strong candidate for this Director role?

A strong candidate will have leadership experience in manufacturing technical operations, expertise in GMP, process optimization, new product transfers, quality investigations like CAPA and NCR, and the ability to inspire teams and drive strategic initiatives.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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