L5 To L6 - F&D Nasal Spray/NDDS TT

SAVA Group; Pune District; Vor Ort; INR 1.200.000 - 1.800.000; Vollzeit

Zusammenfassung

The SAVA Group is seeking a Formulation & Development Scientist – Nasal Dosage Forms to lead nasal formulation development, analytical method development, and regulatory documentation. This role spans pre-formulation through technology transfer, with emphasis on QbD, DoE, and lifecycle management.

You will coordinate cross-functional teams, drive scale-up, and evaluate new excipients and devices for nasal delivery while ensuring adherence to ICH and global regulatory standards.

Qualifikationen

• Experience in nasal formulation development and related pre-formulation studies.
• Familiarity with regulatory guidelines (USFDA, EU, WHO, CDSCO).
• Hands-on with spray characterization and analytical method development.
• Experience with QbD, DoE, and risk assessments.
• Strong documentation and project management skills.

Aufgaben

• Develop nasal formulations (solutions, suspensions, sprays, gels, powders).
• Conduct pre-formulation studies, solubility profiling, and compatibility evaluations.
• Design formulation strategies for new product development and lifecycle management.
• Optimize formulations for stability, sensory attributes, spray characteristics, and patient usability.
• Develop manufacturing processes for nasal formulations and prepare scale-up protocols.
• Support technology transfer to production through documentation, trials and training.
• Coordinate with manufacturing and quality teams during exhibit/validation batches.
• Coordinate analytical method development for assay, impurities, particle size, spray pattern, plume geometry, droplet size distribution, and microbiological parameters.
• Review stability data per ICH and prepare technical reports.
• Prepare master formulas, development reports, justification documents, and technology transfer documents.
• Ensure compliance with regulatory guidelines (US FDA, EU, WHO, CDSCO).
• Support dossier preparation including QOS, PDR, QbD elements, and risk assessments.
• Manage timelines and deliverables for multiple F&D nasal projects.
• Coordinate with cross-functional teams and provide regular project updates to senior management.
• Explore advanced nasal drug delivery technologies and excipients/devices.
• Strong knowledge of nasal delivery systems and regulatory expectations.
• Hands-on with lab equipment for nasal sprays (DPI systems, spray characterization).
• Excellent documentation, communication, and project management skills.

Kenntnisse

Formulation development

Analytical method development

Regulatory knowledge

Project management

Documentation

Nasal delivery systems

DoE

QbD

Risk assessment

Spray characterization

Tools

DPI systems

Spray characterization tools

Nasal spray lab equipment

Jobbeschreibung

Job Description – Formulation & Development (F&D) – Nasal Products

Position: Formulation & Development Scientist – Nasal Dosage Forms

Department: Research & Development / F&D

Key Responsibilities

1. Formulation Development

Develop nasal formulations including solutions, suspensions, sprays, gels, and powders.

Conduct pre‑formulation studies, solubility profiling, and compatibility evaluations.

Design formulation strategies for both new product development and lifecycle management.

Optimize formulations for stability, sensory attributes, spray characteristics, and patient usability.

2. Process Development

Develop manufacturing processes for nasal formulations and prepare scale‑up protocols.

Support technology transfer to the production site through documentation, trials, and training.

Coordinate with manufacturing and quality teams during exhibit/validation batches.

3. Analytical & Stability Studies

Coordinate analytical method development for assay, impurities, particle size, spray pattern, plume geometry, droplet size distribution, and microbiological parameters.

Review and interpret stability data as per ICH guidelines and prepare technical reports.

4. Documentation & Regulatory Compliance

Prepare master formulas, development reports, justification documents, and technology transfer documents.

Ensure compliance with regulatory guidelines (USFDA, EU, WHO, CDSCO, etc.) relevant to nasal dosage forms.

Support dossier preparation including QOS, PDR, QbD elements, and risk assessments.

5. Project Management

Manage timelines and deliverables for multiple F&D nasal projects.

Coordinate with cross‑functional teams like Packaging, RA, QA, QC, SCM, and Production.

Provide regular project updates to senior management.

Explore advanced nasal drug delivery technologies (mucoadhesive systems, preservatives‑free, multidose devices, sustained release).

Support evaluation of new excipients, packaging components (pumps, valves, actuators), and device compatibility.

Strong knowledge of nasal delivery systems, spray devices, and regulatory expectations.

Good understanding of formulation science, QbD, DoE, and troubleshooting.

Hands‑on experience with laboratory equipment related to nasal sprays (DPI systems, spray characterization tools).

Excellent documentation, communication, and project management skills.