QC Manager, Bioanalytical at Thermo Fisher Scientific

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell and Gene TherapyIndustries

Requirements

BS required, MS preferred in a scientific/technical field. PhD in a scientific/technical field is a plus
6-8 years of experience in a quality position within the biological and/or pharmaceutical industry required
Significant experience (implied in bioanalytical QC, method qualification/validation, cGMP compliance, and lab management)

Responsibilities

Provide leadership and scientific/technical expertise for bioanalytical QC and transfer activities, including qualification/validation of analytical methods for cGMP manufacturing and transfer/validation of assay methods
Ensure cGMP compliance, operate within budgets, and supervise bioanalytical lab staff directly and QC scientists/technicians indirectly
Hire, train, set goals, and evaluate performance of staff
Collaborate with departments and project teams for planning and timelines, improve QC services, and maintain safe working conditions
Serve as primary technical liaison with clients and QC Bioanalytical contact for regulatory inspections and client audits
Lead Bioanalytical lab operational readiness plan for on-time approval of analytical equipment and test methods for GMP testing
Build a trained, competent team of QC analysts to support GMP testing
Coordinate daily Quality Control activities for Molecular, Viral, Cell, and Tissue Culture operations and contract testing, ensuring compliance, accuracy, and timeliness
Lead introduction of new technology, equipment, methodologies, and validations
Provide QC leadership and support across VVS organization, facilitate cross-functional communication, and ensure testing processes, metrics, and goals are achieved
Implement and improve systems to drive efficiency
Support internal, external, and regulatory inspections
Assign work, coach staff, and take disciplinary actions
Provide support for method qualification/validation from Assay Development & Analytics and/or clients
Support establishment/enhancement of QC and operational metrics
Provide frequent departmental feedback to senior management
Ensure adequate staffing is hired and trained

Skills

Key technologies and capabilities for this role

cGMPBioanalyticalMethod ValidationAssay TransferQuality ControlGMP ComplianceAnalytical MethodsBiopharmaceuticalsGene TherapyViral VectorsToxicological Testing

Questions & Answers

Common questions about this position

What is the salary for the QC Manager, Bioanalytical position?

This information is not specified in the job description.

Is this role remote or does it require on-site work?

The role reports to the Plainville, MA site, indicating it is an on-site position in a laboratory and office setting.

What are the key responsibilities of this role?

The role involves leading bioanalytical lab operations, building and training a QC team, coordinating testing for Molecular, Viral, Cell, and Tissue Culture operations, ensuring cGMP compliance, and serving as the primary technical liaison with clients.

What is the work environment like at Thermo Fisher Scientific's VVS division?

The work environment is in a cGMP-compliant laboratory and office setting at the Plainville, MA site, focused on enabling gene therapies for genetic and rare diseases, with adherence to GMP safety standards and a standard Mon-Fri schedule.

What makes a strong candidate for this QC Manager position?

Strong candidates will have leadership experience in bioanalytical QC, expertise in cGMP compliance, method validation, and team management, along with the ability to collaborate cross-functionally and serve as a technical liaison with clients.

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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