Aurigene Oncology - Pharmaceutical/Formulation Development Role

Pharmaceutical Development - Formulation Development

Description:

Education Specialization: MSc/MPharm/PhD

Experience: 3-8 years

Salary Offered: 10 LPA to 12 LPA

Key Skills:

- 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 (NBEs).

- Experience in parenteral delivery systems development like Nanoparticulate delivery systems, Lipid based delivery systems etc.

- Proficient in pre-formulation studies of mAbs and ADCs along with its physiochemical & Solid-State characterization.

Job Description:

- 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