Senior Scientist, Parenteral Drug Product Development
Core
Lead formulation and process development for sterile parenteral drug products across preclinical, clinical, and commercial stages.
Role type
Senior Scientist, Parenteral Drug Product Development
Builds
Sterile parenteral drug products (vials, prefilled syringes) for novel therapies
Domain
Biopharmaceuticals / Parenteral Formulation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
sterile drug product development, formulation optimization, aseptic filling, lyophilization, container closure systems, process validation, technology transfer, GMP manufacturing support, quality-by-design risk assessments, regulatory submission authoring, analytical characterization of sterile products
Preferred skills
complex biologics formulation (proteins, antibodies, ADCs), drug delivery system development, statistical software and experimental design
Technologies
aseptic filling, lyophilization, single-use systems, filters, vials, prefilled syringes
Responsibilities
Design and execute formulation/process development studies; Lead sterile product development and technology transfer; Provide technical support during GMP campaigns and validation; Collaborate with drug substance, analytical, device, and regulatory teams; Develop container closure strategies; Author technical and regulatory documents
Seniority
Senior, hands-on IC
