about the company.
a global CRO company offering antibody discovery services
about the team.
Driven by industry veterans in biopharma and antibody engineering
about the job.
- Lead the design and development of formulation of drug substance and drug product, drug product device of antibody-based therapeutics to support clinical development and commercialization
- Lead CMC development to conduct protein formulation development, protein stability and characterization, compatibility study to support clinical operation, leachable and extractable study, tech transfer, and on-floor support of manufacturing, and shipping validation etc
- Compile development and technical reports to support technology transfer and regulatory submission
skills and experience required.
- PhD in chemistry, chemical engineering, biochemistry, or related field
- At least 8+ year hands-on experiences in formulation development in biotech
- Extensive experience in formulation development for monoclonal antibodies, bispecific antibodies, Fc-fusions and other therapeutic proteins