Key Responsibilities

- 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:

- RM Specifications

- Product Specifications (In‑process, Release, Shelf‑life)

- Master Formula Record (MFR)

- RM BOM

- Product Development Report (PDR)

- Technology Transfer documents

- 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

- Solid documentation and data compilation skills

- Ability to work independently on assigned tasks with appropriate escalation

- Compliance‑driven and quality‑focused approach

📌 SENIOR EXECUTIVE – Pulmonary Formulation & Development (IndiaI (Navi Mumbai)
🏢 Alkem Laboratories
📍 Navi Mumbai