Our Client is a powerhouse in the field of protein engineering. They have been growing rapidly over the course of the last few years and are adding key members to their Process Development team as they continue to ramp up.
- Lead process development efforts for the preclinical team.
- Collaborate with the Discovery Research group and evaluate the chemical stability, pH-solubility, dissociation constants of preclinical compounds.
- Responsible to prepare formulations to support in-vivo studies.
- Work with the Process Chemistry team to identify the final form.
- Conduct the pre-formulation studies including the solid-state and solution state characterization of the compound. Analytical methods such as UV-Vis, LC-MS, DSC, DVS, UPLC, HPLC, SEM could be used to conduct the pre-formulation studies.
- Participate in the formulation, process development and manufacturing of drug products.
- Lead Drug Product technology transfer from process development to clinical and commercial manufacturing sites, serve as the technical representative during fill/finish operations and participate in technical troubleshooting. Assist in technical review of batch records for lot release and CMO summary reports.
- Experience with Regulatory Filings including authoring relevant sections of INDs/CTDs is desired
- The applicant should be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Ability to proactively identify issues and develop solutions in a highly collaborative, multidisciplinary environment.
- BS, MS or Ph.D. in Biophysics, Biochemistry, or Biological Science, BS with 10+ years, MS with 6+ years or Ph.D. with 0-3 years industry experience in purifying and analyzing proteins
- Strong technical background and direct hands-on experience with downstream processing unit operations