30 Sep
|
Navlakha Management Services
|
Mumbai
30 Sep
Navlakha Management Services
Mumbai
Job Title
Research Scientist Ophthalmic
Location: Mumbai
Industry: Pharmaceutical & Life Sciences
Department: Research & Development
Employment Type: Full-Time, Permanent
Job Summary
We are looking for a Research Scientist Ophthalmic Formulation Development with hands-on experience in developing and optimizing sterile ophthalmic formulations for regulated and ROW markets.
Key Responsibilities
- Develop and optimize complex ophthalmic dosage forms including solutions, suspensions, emulsions, gels, preservative-free and multidose products.
- Conduct formulation screening, prototype development and support Q1/Q2/Q3 equivalence studies.
- Perform pre-formulation, excipient compatibility and container-closure evaluations.
- Execute stability studies and investigate formulation/process/stability issues.
- Support sterilization, aseptic processing, homogenization and emulsification activities.
- Apply QbD, risk assessment and mitigation principles.
- Prepare/review protocols, technical reports, PDRs and Technology Transfer documents.
- Support laboratory-to-pilot scale-up and Technology Transfer to manufacturing.
- Contribute to dossier preparation, specifications,
regulatory responses and nitrosamine risk assessments.
- Ensure compliance with ICH, GDP and data integrity requirements.
- Collaborate with Analytical Development, Regulatory Affairs, QA and Manufacturing teams.
Candidate Profile
- M.Pharm / Ph.D. in Pharmaceutics, Pharmaceutical Technology or related discipline.
- Relevant experience in ophthalmic formulation development within a pharmaceutical workplace.
- Strong knowledge of sterile manufacturing, aseptic techniques and ophthalmic product development.
- Experience with regulated markets such as US / EU / UK / ROW is preferred.
- Knowledge of QbD, regulatory requirements and product lifecycle management.
- Strong analytical, problem-solving, documentation and communication skills.
Key Skills Ophthalmic Formulation Development | Ophthalmology | Sterile Formulation | Eye Care | Formulation Development | QbD | Scale-Up | Technology Transfer | Stability | Aseptic Processing
Interested candidates can share their updated CV along with current CTC, expected CTC, notice period and current location.
📌 Research Scientist R & D/Tech Transfer - Ophthalmic (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai