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.
2. Selection of the compatible excipients based on their properties as required in such formulations.
3. Selection of suitable devices for such formulations.
4. Pre-formulation Studies: Evaluate API and excipient characteristics such as particle size distribution,
morphology, density, moisture content, flow properties, crystallinity, hygroscopicity etc.
5. Particle Engineering Strategy: Detailed understanding of morphology, particle size distribution,
polymorphism and other essential physical properties of the drug substances.
6. 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.
7. Device–Formulation Compatibility: Evaluate compatibility of the formulation with different
devices/pumps and optimize formulation considering device resistance and aerosolization
characteristics.
8. 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
9. Reference Product Characterization: Conduct systematic characterization of reference/marketed
products to understand formulation, device, physical characteristics, and critical performance
attributes for generic product development.
10. 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.
11. Stability Studies: Plan and evaluate stability studies and investigate the impact of temperature,
humidity, moisture uptake, packaging, and physical on product performance.
12. 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.
13. Troubleshooting: Candidate should have experience related to troubleshooting.
14. Documentation: Prepare and review development reports, BOM/MFR, product development reports,
technology-transfer documents, protocols, risk assessments, QbD documents, and regulatory-support
documentation.
15. 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.
2. Prepare and monitor various protocol bound studies like in-use stability study, photostability study,
device-compatibility study.
3. Maintain accurate and contemporaneous Laboratory Notebooks (LNBs), experimental records,
development data, and material accountability.
4. 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.
2. Problem-Solving: Good problem-solving skills will be desired.
3. 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
