We are seeking a highly motivated and innovative R&D Scientist to join our pharmaceutical development team. The successful candidate will contribute to the design, formulation, development, and optimization of drug products, with a focus on quality, scalability, and regulatory compliance. This role offers the opportunity to work in a collaborative environment with cross-functional teams including Regulatory, Analytical/QC, Quality, Manufacturing, and Business Development.
Key Responsibilities
Conduct research and development of new drug formulations for Global Regulated markets (Nasal – Solution, Spray, DPI, pMDI etc.)
- Follow Quality by Design to plan & execute lab-scale experiments, stability studies, and process development activities including DOE.
- Responsible for managing monographs, validated excel sheets, approved reports (paper and electronic), notebooks and document archival.
- Develop & optimize manufacturing processes in compliance with cGMP requirements.
- Participate in Technology transfer to manufacture pilot, scale up, submission & commercial batches.
- Prepare technical documents, as per cGMP & ICH for execution and manufacturing including batch records, protocols and reports.
- Prepare regulatory submission documents as pe ICH including chemistry manufacturing & controls (CMC), product development report, overall quality summary (OQS) etc.
- Execute CCR, deviation investigation, CAPA, LIR, SOP preparation, internal and support GMP inspection.
- Stay updated with scientific & global regulatory advancements and ensure knowledge sharing with co-workers.
Collaborate with cross-functional teams on project timelines and deliverables
Job Requirements
Master's or Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related field
- 5–10 years of experience in Pharmaceutical R&D for Nasal Product Development.
- Strong documentation, development, regulations (USFDA, EMA), analytical, and problem-solving skills
Excellent communication skills in English (written and spoken)
Preferred
Experience in non-infringing formulation design & 505 B2 for USFDA/EMA.
- Hands on experience on manufacturing & filling equipment, NGI (DUSA, APSD, Plume geometry, breathing simulators) & HPLC.
- Soft skills requirement: Drive for Results, Teamwork, Service Mindset, Embracing Change and Problem-Solving skills.