Formulation Development - Oncology (OSD / Injectable)

Formulation Scientists (Product Development group) for Regulated

Department

Formulation

Market

Experience Required

Location:

1. F&D - Oncology (Injectables)

• Development of activities of Onco injectable formulations for Regulated Markets (US & EU Markets). Additional experience in CA markets is preferable.
• Candidate must have sound knowledge of different techniques like liquid injectable (solution formulation, suspension emulsion formulations) and Lyophilized formulation, specifically for Oncology products.
• Candidate must have equipment handling experience for Autoclave, Dry heat sterilizer and Lyophilizer.
• Responsible for execution of trial batches.
• Responsible for initiation of licenses i.e. Test License, Import License and Manufacturing License for product.
• Responsible for Design and evaluation of formulation trials to develop optimized formula as per QBD approach.
• Responsible for execution of R&D scale up and DOE experiments as per QBD approach.
• Responsible for preparation of Master Formula Card and Product Development Report as per QBD approach.
• Responsible for monitoring of Scale up and Exhibit Batches.
• Responsible for Identifying and Trouble-shooting the critical problems during formulation developments.
• To coordination with ADL, RA, RQA, PD, IPR, TT Departments during Product Development.
• Responsible for query response of filed products.

2. F&D - Oncology (OSD)

• Development of activities of oncology solid dosage for Regulated Markets (US & EU Markets). Additional experience in Canada markets is preferable.
• Candidate must have sound knowledge of different conventional granulation techniques (RMG, Top Spray & Roller Compaction), compression, and coating.
• Additional experience in extended-release formulation and palletization is preferable.
• Responsible for execution of trial batches.
• Responsible for initiation of licenses i.e. Test License, Import License and Manufacturing License for product.
• Responsible for Design and evaluation of formulation trials to develop optimized formula as per QBD approach.
• Responsible for execution of R&D scale up and DOE experiments as per QBD approach.
• Responsible for preparation of Master Formula Card and Product Development Report as per QBD approach.
• Responsible for monitoring/execution of Scale up and Exhibit Batches.
• Responsible for Identifying and Trouble-shooting the critical problems during formulation developments.
• To coordination with ADL, RA, RQA, PD, IPR, TT Departments during Product Development.
• Responsible for health agencies query response of filed products.

Perks & Benefits:

• Dynamic work environment & Career development opportunities
• Work-life balance
• Free transportation
• Canteen facility
• Free insurance coverage for self, spouse, and kids

maitrivakil@unisonpharmaceuticals.com

Regards,

Dr. Maitri Vakil | Senior Manager - HR