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Aurigene Oncology Limited
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Scientist - Pharmaceutical Development

Scientist - Pharmaceutical Development

Aurigene Oncology Limited

5 - 9 years

0 Lacs

karnataka

Posted:1 day ago| Platform: Shine logo

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Skills Required

development scale up manufacturing monoclonal antibodies stability studies gmp bioavailability bispecific antibodies trispecific antibodies antibody drug conjugates new biological entities parenteral delivery systems nanoparticulate delivery systems lipid based delivery systems preformulation studies physiochemical characterization solidstate characterization in silico output interpretation preclinical formulation development pk studies tox studies biopharmaceutical properties lipidbased delivery systems nanoparticulate systems biodegradable polymeric systems enabling formulations scientific processes lab equipmentinstruments safety procedures health procedures en

Work Mode

On-site

Job Type

Full Time

Job Description

As a Scientist in Pharmaceutical Development, you will be responsible for planning and executing various tasks related to the 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). Your key responsibilities will include: - Significant experience in development, scale up, and manufacturing of drug products for mAbs, ADCs, etc. - Experience in parenteral delivery systems development like Nanoparticulate delivery systems, Lipid based delivery systems. - Proficient in pre-formulation studies of mAbs and ADCs along with physiochemical & Solid-State characterization. - Proficiency in interpreting in silico output on mAb developability and strategically using it for experimentation. - Hands-on experience in preclinical formulation development of mAbs and ADCs. Qualifications required for this role include: - Proficiency in planning and executing preclinical formulation development of mAbs and ADCs. - Ability to plan and execute pre-formulation studies, stability studies, etc., for mAB and ADC projects. - Experience in formulation development of New biological entities from mAB and ADC platform for human clinical studies. - Proficiency in executing 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). In addition to the above, you will also contribute scientifically to overall pharmaceutical development processes, prepare protocols, guidelines, SOPs for lab equipment/instruments and processes, and adhere to systems and processes pertaining to safety, health, and the environment. If you are selected for this role, you will be expected to demonstrate competencies in Presentation & Communication Skills, Interpersonal Skills, Excel Skills, Scientific Report Writing, and Team Management.,

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Scientist - Pharmaceutical Development