Scientist III, Manufacturing Sciences at Thermo Fisher Scientific

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Degree in biochemical engineering, chemical engineering, or related scientific field (e.g., molecular biology, virology, biochemistry); advanced degree preferred
B.S. with 8+ years, Master’s with 6+ years, or PhD with 3+ years of professional experience
Technical expertise in downstream biopharmaceutical manufacturing and/or process development
Experience with automated chromatography systems (AKTA) and automated tangential flow filtration (Repligen)
Expertise in late stage/commercial technology transfer, process characterization, and process validation for biopharmaceutical/gene therapy vector manufacturing (preferred)
Knowledge of GMP and regulatory requirements for biopharmaceutical manufacturing, specifically cell and gene therapy vector production
Ability to work independently and as part of a team
Proficiency in operating in a fast-paced, dynamic environment while managing multiple projects
Project management skills (desirable)
Ability to speak effectively before groups of customers
Excellent investigational skills and ability to solve technical issues
Ability to compile, analyze, and interpret data; write routine reports and correspondence
Strong interpersonal skills for verbal and written communication
Legally authorized to work in the United States now and in the future, without sponsorship
Ability to pass a comprehensive background check, including drug screening

Responsibilities

Serve as MST process lead for downstream technology transfer activities in manufacturing viral vectors following cGMP guidelines
Collaborate with other sites or clients to ensure success of process transfer and scale-up
Ensure effective information flow, risk assessment, timeline execution, issue resolution, and documentation for multi-departmental teams (Process Development, Manufacturing, Quality, Project Management)
Author detailed process definition, facility fit, and raw material risk assessments
Author PPQ protocols and reports; oversee execution of PPQ and related activities
Develop sampling plans with clients and incorporate them into cGMP batch documentation
Monitor and trend process performance, including input and output parameters
Identify opportunities to improve systems and practices

Skills

Downstream Processing

Viral Vectors

cGMP

Technology Transfer

PPQ Protocols

Risk Assessment

Biochemical Engineering

Process Development

Manufacturing Sciences

Gene Therapy

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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