Formulation development -DPI

Role & responsibilities

Job Title: AM / DM Formulation & Development (DPI)

Job Responsibilities:

• Candidate will be responsible for independently developing and optimizing Dry Powder Inhalation (DPI) formulations, including single and combination products.
• Candidate will be responsible for preformulation studies covering API/excipient properties, particle size, morphology, flow, moisture and compatibility.
• Candidate will be responsible for excipient/carrier selection, API particle engineering and blend optimization.
• Candidate will be responsible for evaluating formulation compatibility with capsule, blister, reservoir and multidose DPI devices.
• Candidate will be responsible for evaluating DPI performance parameters including DDU, APSD, FPD, FPF, MMAD, GSD and emitted dose.
• Candidate will be responsible for reference product characterization and QbD-based formulation/process development using QTPP, CQA, CMA, CPP, risk assessment and DoE.
• Candidate will be responsible for process development, scale-up, stability studies and technology transfer to pilot/commercial sites.
• Candidate will be responsible for troubleshooting formulation and process-related issues and providing technical support during exhibit, validation and commercial batches.
• Candidate will be responsible for preparing development reports, BOM/MFR, protocols, risk assessments, QbD documents and technology-transfer documentation.
• Candidate will be responsible for coordinating with ADL for DPI analytical testing and supporting regulatory, stability, BE/PK and comparative in-vitro studies.

Candidate Profile:

• Candidate should have M.Pharm in Pharmaceutics.
• Candidate should have 4–6 years of relevant experience in Formulation & Development.
• Candidate should have significant hands-on experience in DPI/OINDP formulation development.
• Candidate should have strong knowledge of powder properties, aerosolization, APSD/NGI, FPD, FPF, MMAD and delivered-dose studies.
• Candidate should have experience in scale-up, technology transfer, stability and troubleshooting of DPI products.
• Candidate should have strong scientific, analytical, problem-solving and project execution skills.

Preferred candidate profile