We are hiring for Manager/ Sr. Manager - Formulations Development for a Reputed Pharma company in Ambernath, Thane Location.
- Formulation and development of Oral Dosage Forms, Parenterals and lyophilized formulations for different regulated markets like USA, EU, Canada, Australia, South Africa, and ROW markets.
- Development of NDDS- ANDA/ NDF/ NDA/ SNDA/ NCE Projects.
- Overall in charge of the assigned project
- Leading a team of Research Officer and Research Associates
- Preparation of the study plan/ protocol
- Comply with project timelines
- Development & writing of Product Proposal.
- Patent Evaluation and Strategy Proposal.
- Conceptualization of Non-Infringement Strategies.
- Manage the operations of the pilot plant.
- Planning and monitoring execution of pre-formulation studies, prototype formulation development, formula optimization, process optimization and validation activities and effective project management to meet the product development timelines.
- Designing and implementing formulation strategies for development of generic drug products.
- Stability studies - solving problems encountered during stability studies
- Scale-up / Process optimization batches execution
- Document checks prepared by subordinates Viz. PDR, MFC, BPR, SOP, CTD.
- Compilation of other R&D data and support for regulatory submission (CTD)
- Regulatory Filing Support for ANDA/NDF/NDA/NCE.