As a part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Location/Division Specific Information
How will you make an impact?
The Scientist III (QC Bioassay) role performs analytical methods to support biopharmaceutical production. 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 assays for process impurity assays such as Host Cell Protein by ELISA, residual ligand by ELISA and potency by either ELISA or Cell-based assays.
Follow GMP regulations and test method instructions to perform assays, qualify reagents, and support method qualifications and validations.
Responsible for analysis of analytical data, including control trending, and collaborate with the quality team for method lifecycle review.
Recognize and propose solutions for potential problems and evaluate method effectiveness from a QC standpoint.
Carries out duties in compliance with all local, state, and federal regulations and guidelines including FDA, EPA, and OSHA.
Aligns with all company and site policies and procedures.
Interacts with auditors and clients during visits and tours.
Trains more junior level staff.
Other job duties as assigned.
Who we are looking for: experience, skills & abilities
High proficiency with micro-pipettes, both single channel and multi-channel.
Knowledge and expertise in performing plate based assays using microtiter plate readers. Preferable experience using SoftMax Pro application.
Technical experience with the following assay formats: colorimetric and fluorescent based detection of impurities using sandwich ELISA. Cell culture and cell based potency assay knowledge.
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
Bachelor in Molecular Biology / Chemistry / Biochemistry / Chemical Engineering, or a related field.
Experience
With Bachelor's degree, minimum of 2 years of experience related to the job description. With Master's degree, no experience required.
Knowledge, Skills, Abilities
Passion for supporting the successful manufacturing and release of products to support patients!
High attention to detail.
Outstanding technical writing skills.
Strong social skills including active listening, conflict resolution, and the ability to handle time-sensitive tasks appropriately.