Job description
Self Starter, Highly motivated Scientist, excellent written and oral skills
Should be able to supervise method development, method qualification and sample anlysis for 2-3 assets in regulated bioanalysis of Pharmacokinetics, immunogenicity and pharmacodynamics for large molecules (monolconal antibodies and fusion proteins)
Should have in depth knolwedge of Ligand bindig assays, MSD, ELISA, Conjugation of proteins.
Should be able to author and review Method development, Qualification/validation, sample analysis reports and clinical study related documents
Should have knowledge and experience of regulatory requirments of FDA, EMA, ANVISA, CDSCO guidelines
Proficiency in LIMS software, MSD, Softmax pro is needed
Role: Formulation Scientist
Industry Type: Pharmaceutical & Life Sciences
Department: Research & Development
Employment Type: Full Time, Permanent
Role Category: Pharmaceutical & Biotechnology
Education
UG: Any Graduate
PG: Any Postgraduate
Key Skills
SupervisorDocument reviewAuthorPharmacokineticsELISA