Scientist I, Biologics Product Analytics-CMC
Exton, PA (Research)
Roles and Responsibilities:
- Develop and apply biochemistry, biophysics methods, immunoassays, and other state of the art analytical technologies to analyze and characterize oligonucleotides, cell and gene products, biotherapeutic proteins, their conjugates, and variants.
- Perform method development, validation, tech transfer, product characterization, impurity profiling, routine and stability testing across varieties of biologics products.
- Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
- Prepare and review notebooks in compliance with Frontage CMC SOPs.
- Maintain qualification and compliance of instruments, and conduct technical and instrumental troubleshooting.
- Manage projects from initiation to completion and ensure the projects are on time, on budgets, and meeting pre-established quality standards.
- Under guidance of supervisor, contribute and/or lead the creation of new service portfolios for emerging biotherapeutics.
- PhD in Biological Science, Biochemical Engineering, or related discipline with 0-2+ year’s relevant industrial analytical development experience, or MS with 0-4+ year’s analytical development experience for biologics.
- It is a plus to have experience in applying biochemistry (e.g., icIEF, CE-SDS, HPLC, LC-MS, ELISA, etc.) and biophysics (CD, DSC, DLS, etc.) analytical method for characterization and release of biologics such as recombinant proteins and monoclonal antibodies.
- Excellent oral and writing communication, and organization skills.
- Demonstrated enthusiasm to learn and collaborate.
Employment at Frontage Labs:
Frontage Labs offers competitive salary and generous benefits including paid vacations, health insurance, 401K, disability insurances, and many others. On top of these benefits, we offer many opportunities to help you advance your career. So come, and join us today!