About this role
Job title: Biologics Formulation Development Lead
About the Role The Biologics Formulation Development Lead will lead a team of formulation development scientists to develop novel formulations for pipeline biosimilar products (mAbs, fusion proteins, bispecifics and ADCs). The role supports transfer of formulation and drug product processes to scale-up and tech transfer groups, and focuses on protein stability and degradation pathways to guide development decisions.
What You'll Do
- Lead a team of formulation development scientists
- Develop novel formulations for pipeline biosimilar products (mAbs, fusion proteins, bispecifics and ADCs)
- Support the transfer of formulation and drug product processes to scale-up and tech transfer groups
- Manage formulation and DP process development activities with deep understanding of protein stability and degradation pathways
- Develop platform based high throughput analytical methods for formulation development
- Support regulatory filing activities
What We're Looking For
- Demonstrated experience with formulation development of biologics and drug product processes from bench to pilot scale
- Expertise in analytical and characterization methods (HPLC, UPLC, CE-SDS, MFI, DLS and LC-MS) and unit operations required for drug product manufacturing
- Experience in DP process characterization using design of experiments (DoE)
- Expertise in drug device development (safety device and autoinjector) for regulated markets
- Excellent verbal and written communication, problem solving, and organizational skills
Compensation & Benefits Benefits include joining and relocation support, family support (maternity and paternity benefits), learning and development opportunities, medical coverage for you and your family, and life coverage for you. You are trained on data up to October 2023.