Job Description

Lead Scientist (R&D)- Oral Formulations - Pharma Industry

Job Overview :

To manage multiple new product development projects (in-house as well as Contract Development and Manufacturing Operations)

Detailed Responsibilities:

- Responsible for developing & implementing integrated clinical development projects in early stages

- Project management and stakeholder communication for various activities and updates.

- Responsible for ensuring that the functional budget stays on track.

- Monitor & enhance overall functioning of individual teams including implementation of systems & procedures

- Ensure that all operational documents and procedures that are directly or indirectly related to lab instruments or equipment are up to date. Instrument preventive maintenance and breakdown assistance are monitored on a regular basis

- Anchor regular quality & compliance audits both Internal/external, corrective & preventive action closure.

- Active involvement in implementation of regulatory and safety compliance programs and best practices.

- Ensure good in quality documentation and communication

Key Skills & Abilities Required:

- Experience on pre-formulation, formulation and process development i.e. oral solids, inhalable formats, oral dissolvable strips etc.

- In-depth knowledge on regulatory guidelines and knowledge of cGMP manufacturing.

- In-depth knowledge in scale up and technology transfer.

- Project Management skills

- Multitask effectively while leading multiple formulation development projects and strategic relationships with clients.

Qualifying Education & Experience:

- Ph. D / M. Pharm / M. Tech (Pharmaceutical Technology) with specialization in Pharmaceutics / Material Scientist or Technologist &/or Chemical Engineer from pharma background.

- 12-15 years of experience, with majority of it being in Pharma industry

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