Scientist II, Process Development

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information

How will you make an impact?

Responsible for developing or transferring analytical methods to support biopharmaceutical process development. You will work within an interdisciplinary team of scientists where you will learn and supply your skills and ideas to projects.

What will you do?

• Perform laboratory experiments to develop, assess or transfer product specific binding ELISAs and process impurity assays such as Host Cell Protein by ELISA, residual capture ligand by ELISA and residual DNA by qPCR for biologics/biotechnological products.
• Help develop and build the foundation of a biochemical technical team by implementing equipment, standard practices and policies.
• Interpret client documents and literature to strategize approaches for successful method development, qualification, and/or method transfer activities.
• Responsible for performing in-depth analysis of analytical data and collaborate with the analytical team for method lifecycle review.
• Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists, quality control, quality assurance, process engineers and our customers.
• Writing Standard Operating Procedures (SOPs), analytical method development and establishment plans/reports.

Who we are looking for: experience, skills & abilities

• Technical experience with the following assay formats: colorimetric and fluorescent based immunoassays (e.g., ELISA) and biochemical assays. Residual DNA determination using quantitative PCR (qPCR) is beneficial.
• Knowledge and expertise in performing plate based assays using microtiter plate readers. Preferable experience using SoftMax Pro application.
• Experience using automated extraction procedures is helpful.
• Understand ICH method validation guidelines to assess method performance.
• Ability to work independently with excellent communication and prioritization skills.

How will you get here?

Education

• Laboratory Technician, Bachelor's or Master's degree in Molecular Biology / Chemistry / Biochemistry / Chemical Engineering, or a related field.

Experience

• As a lab technician or with Bachelor's degree, 5 years of proven experience related to the job description. 2 years with Master's degree.

Knowledge, Skills, Abilities

• Passion for learning and guiding peers the analytical methods required for successful process development!
• High attention to detail.
• Strong desire to learning new skills.