Scientist II, Parenteral Drug Product Development
Core
Design and execute formulation and process development studies for sterile parenteral drug products to support preclinical, clinical, and commercial development.
Role type
Scientist II, parenteral drug product development
Builds
Sterile parenteral drug products (vials, prefilled syringes) and container closure systems
Domain
Biopharmaceuticals / Parenteral Formulation
Required skills
sterile parenteral formulation development, aseptic filling, lyophilization, container closure systems, process validation, PPQ, technology transfer, CMC documentation, experimental design, data analysis
Preferred skills
biologics formulation, high-concentration protein formulations, drug delivery systems, targeted conjugate molecules, statistical software
Technologies
aseptic filling, lyophilization, single-use systems, filters
Responsibilities
Design and execute formulation and process development studies; Provide technical support during GMP manufacturing campaigns and process validation; Collaborate with cross-functional teams on oligonucleotide programs; Author technical reports, protocols, and CMC documentation for regulatory submissions.
Seniority
Mid-level Scientist (0-4 years with PhD or 4+ with MS)
