SENIOR EXECUTIVE – Pulmonary Formulation & Development (IndiaI

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
• Strong documentation and data compilation skills
• Ability to work independently on assigned tasks with appropriate escalation
• Compliance‑driven and quality‑focused approach