21 Sep
|
HRD House
|
Pune
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 solid scientific, analytical, problem-solving and project execution skills.
Preferred candidate profile
📌 Formulation development -DPI (Pune)
🏢 HRD House
📍 Pune