As Celldex’s pipeline continues to progress, it necessitates the development and implementation of a broader array of analytical methodologies for product characterization, release and stability testing. In this role you would have the opportunity to enhance our analytical and biophysical characterization proficiencies by providing expertise on analytical methodologies that are currently performed in-house for product characterization purposes such as LC-MS/MS, AF4/HF5 and DLS. You would also develop new capabilities such as glycan mapping using LC-MS/MS. Additionally, you would provide analytical support to our team of associate scientists as well as providing cross-functional support to Research and Development, Process Development, Quality Control and Manufacturing.
- Design, perform and analyze experiments to characterize a variety of biological molecules to address scientific and technical questions. Develop new methods as needed.
- Conduct characterization testing for GMP refence materials and drug substance batches and document in CMC section of IND.
- Author and review technical reports.
- Communicate results effectively directly to supervisor or in a group setting.
- BS + 8 / MS + 5 / PhD + 2 in protein science or life science.
- 2-8 years’ experience in the Biotechnology/Pharmaceutical industry working with biological products.
- Experience with HPLC, LC-MS/MS (intact mass, peptide mapping, glycan mapping) required. CD, SDS-PAGE, CE-SDS (CGE), ELISA, cIEF, cell culture, DLS, DSC, DSF, SEC-MALLS, Isothermal Chemical Denaturation and standard analytical techniques is preferred, but not required.
- The ability to think and solve problems creatively from a critical and analytical perspective.
- Strong interpersonal skills.
- Strong communication and organizational skills required, as is excellent attention to detail.
- Exceptional self-management skills, ability to work both independently & as part of a team.