Immunoassay Method Development and Validation Group Leader at Thermo Fisher Scientific

Richmond, Virginia, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

NoVisa

Biotechnology, Pharmaceuticals, Life Sciences, Clinical ResearchIndustries

Requirements

Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar, with 8+ years of previous experience that provides the knowledge, skills, and abilities to perform the job (or equivalent combination of education, training, & experience)
OR Master's degree with 6+ years of previous experience that provides the knowledge, skills, and abilities to perform the job
OR PhD with 4+ years of previous experience that provides the knowledge, skills, and abilities to perform the job
1+ year of leadership responsibility
Solid understanding and knowledge of biology, chemistry, and immunoassays
Legally authorized to work in the United States without sponsorship
Ability to pass a comprehensive background check, including a drug screen
Ability to work fully onsite in a laboratory setting with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Independently performs immunochemistry laboratory experiments and acts as the technical project leader for multiple projects
Designs and executes experiments, reviews and analyzes data, writes reports and other technical documents with minimal supervision
Interacts with clients around technical data, scientific issues, and project status; responds to client needs
Mentors, trains, and coordinates laboratory activities of other team members to achieve project goals within established project timelines
Ensures high-level science, quality, and compliance to protocols, methods, SOPs, client criteria, Good Laboratory Practices (GLP), and regulatory guidance
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers
Performs immunoassay method development, validation, and troubleshooting in support of pharmacokinetic, toxicokinetic, pharmacodynamic, and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics)

Skills

Key technologies and capabilities for this role

ImmunoassayMethod DevelopmentMethod ValidationLaboratory TechniquesPPEResearch and DevelopmentBioanalysis

Questions & Answers

Common questions about this position

What benefits are offered for this position?

The role offers full time benefits, annual bonus, 401k match, and PTO.

Is this a remote role or onsite?

This is a fully onsite role based at the BIOA Laboratory in Richmond, VA, with no relocation assistance provided.

What are the key responsibilities and skills needed for this role?

The role requires performing immunoassay method development, validation, and troubleshooting, acting as technical project leader, designing and executing experiments, data analysis, client interaction, mentoring team members, and ensuring compliance with GLP and regulations.

What is the work schedule and environment like?

It's a standard Monday-Friday first shift from 8AM-5PM EST in a laboratory setting requiring some PPE like safety glasses, gowning, gloves, lab coat, and ear plugs.

What qualifications make a strong candidate for this position?

Strong candidates must be legally authorized to work in the US without sponsorship, able to pass a comprehensive background check including drug screen, and have expertise in immunoassay method development for biologics with leadership and mentoring experience.

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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