Scientist/Senior Scientist, Pharmaceutical Analysis
Location : Exton, PA Full-time Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. 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.
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