Manager - Formulations Development for Regulated Markets

Nurture Consultancy
  • Thane
  • Confidential
  • 9-14 years
  • 05 Feb 2015

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

We are hiring for Asst. Manager/ Manager - Formulation for a Reputed Pharma company in Ambernath, Thane Location.

Key Deliverables:
- Formulation and development of Oral Dosage Forms, Parentrals 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.

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Nurture Consultancy