Scientist - Pharmaceutical Development

Role & responsibilities

• Plan and execute preclinical formulation development of mAbs and ADCs to support programs during initial stage.
• Plan and execute pre-formulation studies, stability studies etc for mAB and ADC projects during early stages of pre-clinical development.
• Plan and execute formulation development of New biological entities from mAB and ADC platform for human clinical studies.
• Execute approaches and strategies for scale up, tech transfer of mAB and ADC drug products to manufacturing facilities.
• Coordination and execution of drug products of mAB and ADC under GMP set up for clinical trials with appropriate documentation.
• Support development of enabling formulations for improving the bio-pharmaceutical properties and bioavailability of New Chemical Entities (NCEs) like lipid-based delivery systems, nano-particulate systems, biodegradable polymeric systems etc.
• Contribute scientifically on overall pharmaceutical development processes.
• Prepare protocols, guidelines, SOPs for lab equipment/instruments and processes.
• Adhere to systems and process pertaining to safety, health and environment.

Preferred candidate profile

• Significant experience in development, scale up and manufacturing of drug products for monoclonal antibodies (mAb), bi-specific, tri-specific antibodies and Antibody Drug Conjugates (ADC) of New biological entities (NBE).
• Experience in parenteral delivery systems development like Nanoparticulate delivery systems, Lipid based delivery systems etc.
• Proficient in pre-formulation studies of mAbs and ADC’s along with its physiochemical & Solid-State characterization.
• Proficiency in interpreting in silico output on mAb developability and strategically use for experimentation.
• Hands on experience in preclinical formulation development of mAb’s and ADC’s for supporting PK, efficacy and tox studies.