Lead - Formulation & DP - Biosimilars

The successful candidate will be responsible for Biologics formulation development activities

1) Lead a team of formulation development scientists

2) Responsible for developing novel formulations for pipeline biosimilar products (mAbs, Fusion proteins, Bispecific and ADC's)

3) Support the transfer of formulation and drug product process to scale-up and tech transfer groups

4) Manage the formulation and DP Process development activities using in-depth scientific understanding on protein stability and degradation pathways.

5) Responsible for developing platform based high throughput analytical methods for formulation development

6) Support regulatory filing activities

Qualifications:

Demonstrated experience with the formulation development of biologics and drug product process 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 studies using design of experiments (DoE). Expertise in Drug device development (Safety device and Autoinjector) for regulated market. Good verbal and written communication skills good problem solving abilities and good organizational skills.

Education:

PhD in Pharmaceutics, Biochemistry, Biotechnology, Chemical Engineering with 10+ years experience in biologics formulation development and drug product development.

Master degree in Pharmaceutics, Biochemistry, Biotechnology, Chemical Engineering with 18+ years experience in biologics formulation development and drug product development.