Conduct literature search and technical review to support initiation of pulmonary product development for the domestic market.
Execute formulation and development activities for pulmonary dosage forms including Dry Powder Inhaler (DPI), Metered Dose Inhaler (MDI), Nebuliser and Breath‑Actuated Inhaler (BAI) under guidance of the Manager/Group Leader.
Perform pre‑formulation studies, prototype formulation, and process development as per agreed development plans.
Support preparation and submission of regulatory applications such as Form‑29 and CT‑11/CT‑15 for assigned development projects.
Assist in tracking and timely renewal of Test License and Import License, ensuring compliance requirements are met.
Participate in manufacturing of development batches, lab‑scale and stability batches, ensuring adherence to approved protocols.
Monitor stability studies, compile stability data, and support interpretation of results.
Ensure stability and robustness of formulations at various development stages, escalating observations to seniors as required.
Compile trial batch data, analytical observations, and development reports, and discuss findings with Manager/Group Leader for further direction.
Assist in root‑cause analysis and troubleshooting of formulation or process‑related challenges.
Support scale‑up and exhibit batch execution at manufacturing or pilot locations under supervision.
Ensure online completion and maintenance of Batch Manufacturing Records (BMR) and Laboratory Notebooks (LNB).
Coordinate for raw material (RM), excipients, semi‑finished (SF) and finished goods (FG) code creation and raise indent requests as per development needs.
Proactively support procurement of materials, reference standards, and change parts to avoid project delays.
Assist in uploading Vendor Suitability Reports (VSR) in SAP after review and approval.
Raise CRM requests for RM, excipients, SF and FG codes as per internal procedures.
Initiate Change Control and e‑DMS requests for preparation and review of documents including:
Ensure laboratory cleanliness, controlled temperature & humidity conditions, and compliance with cGMP standards during formulation and manufacturing activities.
Follow safety, health, and environmental guidelines during laboratory operations and handling of materials.
Collaborate effectively with Analytical R&D, QA, Regulatory, Supply Chain and Manufacturing teams to support development timelines.
Behavioral & Functional Expectations
Good hands‑on technical knowledge of pulmonary formulations
Strong documentation and data compilation skills
Ability to work independently on assigned tasks with appropriate escalation
