L 5 - NDDS/TT

Key Responsibilities & Accountability – Handled Individually

1. Development of Inhalation Dosage Forms: Independently plan and execute formulation development

of Nasal Spray, Solutions, Suspensions, Drops etc. including single and combination products.

1. Selection of the compatible excipients based on their properties as required in such formulations.
2. Selection of suitable devices for such formulations.
3. Pre-formulation Studies: Evaluate API and excipient characteristics such as particle size distribution,

morphology, density, moisture content, flow properties, crystallinity, hygroscopicity etc.

1. Particle Engineering Strategy: Detailed understanding of morphology, particle size distribution,

polymorphism and other essential physical properties of the drug substances.

1. Deep understanding of the process variables for lab-scale and scale-up: Develop and optimize

• processes considering mixing time, speed, fill weight, segregation risk, content uniformity &
• viscosity of the formulation.

1. Device–Formulation Compatibility: Evaluate compatibility of the formulation with different

• devices/pumps and optimize formulation considering device resistance and aerosolization
• characteristics.

1. Product Performance Evaluation: Interpret critical performance data including:

• a. Delivered Dose Uniformity / Uniformity of Delivered Dose
• b. Droplet Size Distribution (DSD)
• c. Plume Geometry
• d. Spray Pattern
• e. Device retention/deposition

1. Reference Product Characterization: Conduct systematic characterization of reference/marketed

• products to understand formulation, device, physical characteristics, and critical performance
• attributes for generic product development.

1. QbD-Based Development: Define and evaluate QTPP, CQAs, CMAs, and CPPs and apply risk

• assessment, Design of Experiments (DoE), and scientific principles during formulation/process
• optimization.

1. Stability Studies: Plan and evaluate stability studies and investigate the impact of temperature,

humidity, moisture uptake, packaging, and physical on product performance.

1. Technology Transfer: Execute formulation and process transfer from R&D to pilot/commercial

• manufacturing sites and provide technical support during scale-up, exhibit/registration, validation,
• and commercial batches.

1. Troubleshooting: Candidate should have experience related to troubleshooting.
2. Documentation: Prepare and review development reports, BOM/MFR, product development reports,

• technology-transfer documents, protocols, risk assessments, QbD documents, and regulatory-support
• documentation.

1. Literature & Patent Evaluation: Conduct scientific literature, innovator-product, regulatory, and

• patent searches to support formulation strategy and identify potential development or patentability
• opportunities.

Secondary Responsibilities

• Coordinate with ADL for development and interpretation of specific analytical and performance
• testing, particularly DSD, Plume geometry, Spray Pattern, Viscosity, Delivered Dose Uniformity.

1. Prepare and monitor various protocol bound studies like in-use stability study, photostability study,

device-compatibility study.

1. Maintain accurate and contemporaneous Laboratory Notebooks (LNBs), experimental records,

development data, and material accountability.

1. Support preparation of samples and documentation for stability, exhibit batches, BE/PK/clinical

studies, regulatory submissions, and comparative in-vitro studies

Soft Skills required

1. Scientific & Analytical Thinking: Ability to correlate formulation variables, powder properties,

device characteristics, and aerodynamic performance.

1. Problem-Solving: Good problem-solving skills will be desired.
2. Ownership & Execution: Ability to independently manage assigned development activities within

defined project timelines.

Education & Qualification

1. Education: M. Pharm in Pharmaceutics
2. Experience: 4-6 years of relevant experience in Formulation & Development, preferably with

significant hands-on exposure to Nasal Spray/Solutions/Suspensions/Drops product development