Associate Scientist IV, Injectable Drug Product Development
Core
Develop injectable formulations and drug product processes for biotherapeutic candidates including proteins, oligonucleotides, and peptides.
Role type
Senior IC formulation scientist (injectable drug products)
Builds
Injectable drug products (proteins, oligonucleotides, peptides) for clinical and commercial supply
Domain
Biotechnology / Pharmaceutical formulation
Required skills
Formulation development, stability studies, extractables and leachables (E&L) assessment, analytical method development, GMP fill finish processes, liquid chromatography (SEC, IEX, HIC), capillary electrophoresis, regulatory submission support, protein/peptide chemistry knowledge
Preferred skills
cGMP and quality guidelines knowledge
Technologies
Empower, JMP, iCE, LabChip GXII Touch
Responsibilities
Execute formulation screening and stability studies, build expertise in in-use and E&L assessments, support analytical method development and optimization, support development and tech transfer of GMP fill finish processes, write internal technical reports, assist in preparation of external regulatory submissions (IND, BLA)
Seniority
Senior, hands-on IC
