Associate Scientist, Formulation Development

Role Summary

Associate Scientist to support all stages of pre-clinical, clinical, commercial formulation, and drug product development for various drug product modalities. Apply biochemical and biophysical methods to carry out developability assessment and formulation development studies on monoclonal antibody-based therapeutics, to support drug substance and drug product development.

Responsibilities

• Design and execute phase-appropriate formulation development studies, such as formulation screening, stability, and compatibility studies, to support formulation and drug product development for early and late-stage development programs.
• Conduct biochemical and biophysical assessments and pre-formulation studies to support evaluation of preclinical drug candidates.
• Characterize drug product (lyophilized or liquid) formulation to support process development and manufacturing of clinical drug substances and drug products.
• Provide technical support for development, technology transfer and manufacture of drug substance and drug products and collaborate with cross-functional teams.
• Document findings and lab records in electronic laboratory notebook by following the organizational best practices and policies.
• Author protocols, technical documents for internal use and support regulatory filings.
• Participate in meetings and present study results in department meetings or cross-functional team meetings.
• Take part in the general laboratory and instrument maintenance.

Qualifications

• B.S. or MS degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, Biomedical Engineering, Analytical Chemistry, Chemical Engineering, or a related discipline with hands-on laboratory experience. Relevant industry or intern experience is preferred.
• The ability to design and execute experiments, as well as interpret, document, and communicate results with minimal supervision is required.
• Strong technical knowledge base and relevant experience with protein/peptide chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development and biomolecule product development is desirable.
• Hands-on experience with biochemical and biophysical techniques for protein characterization, including chromatography (SEC, IEX, RP), viscosity, gel electrophoresis (CE-SDS, MCE, cIEF, iCE), particle size (DLS, HIAC, MFI), spectroscopy (UV-Vis, CD, AUC, fluorescence), and thermostability characterization (DSC, DSF) is desirable.

Skills

• Strong organizational, detail-oriented, and self-motivated with a passion for science and innovation.
• Ability to work in a fast-paced environment and manage multiple tasks.
• Strong teamwork and excellent interpersonal, oral, and written communication skills.

Education

• B.S. or MS degree in relevant scientific field as listed above.