Job Title

Deputy Manager / Assistant Manager R&D; / Technology Transfer Ophthalmic Formulations

Location: Mumbai, Maharashtra

Department: Research & Development / Technology Transfer

Experience: Approximately 7 to 15 years in pharmaceutical R&D; / Technology Transfer, preferably ophthalmic formulations

Qualification: M. Pharm / B. Pharm / M.Sc. / relevant pharmaceutical qualification

Job Summary

We are looking for an experienced Deputy Manager / Assistant Manager R&D; / Technology Transfer to support the development, scale-up, optimization, and technology transfer of ophthalmic pharmaceutical formulations. The role will involve coordination between R&D;, Manufacturing, Quality, Regulatory, Engineering, and other cross-functional teams to ensure successful transfer of products from laboratory/pilot scale to commercial manufacturing.

Key Responsibilities

- Develop, optimize, and troubleshoot ophthalmic formulations such as eye drops, ophthalmic suspensions, emulsions, gels, and other sterile dosage forms.
- Execute formulation development activities from laboratory scale through pilot and commercial scale-up.
- Prepare and review technology transfer documents, development reports, BMR/BPR-related documents, protocols, and process parameters.
- Transfer products/processes from R&D; to manufacturing in accordance with approved procedures and GMP requirements.
- Conduct scale-up and technology transfer trials and coordinate manufacturing/engineering activities during trials.
- Identify and resolve formulation, process, equipment, and manufacturing-related issues during technology transfer.
- Establish and optimize critical process parameters (CPPs) and critical quality attributes (CQAs).
- Support development and optimization of sterile manufacturing processes for ophthalmic products.
- Coordinate with QA, QC, Production, Engineering, Regulatory Affairs, Packaging,



and Supply Chain for successful product transfer.
- Review analytical and stability data and support investigation of OOS/OOT, deviations, and process-related issues.
- Support process validation, cleaning validation, hold-time studies, and exhibit/registration batches as applicable.
- Prepare technical reports, development reports, trial protocols, risk assessments, and technology-transfer documentation.
- Participate in QbD, risk assessment, DoE, process optimization, and continuous improvement activities.
- Support regulatory requirements and provide technical information/documents for CTD/ANDA/DMF/registration dossiers, where applicable.
- Coordinate with manufacturing sites and troubleshoot issues observed during commercial batches.
- Maintain compliance with GMP, GLP, data integrity, EHS, and applicable regulatory requirements.
- Support investigation and implementation of CAPA and change controls related to formulation/process development and technology transfer.
- Evaluate current technologies, excipients, packaging components, and manufacturing processes relevant to ophthalmic products.
- Mentor junior team members and coordinate project activities to meet development and transfer timelines.

Key Skills Required
- Strong knowledge of ophthalmic formulation development.
- Experience in sterile/aseptic pharmaceutical manufacturing processes.
- Hands-on experience in technology transfer and scale-up.
- Understanding of ophthalmic product formulation, process optimization, and troubleshooting.
- Knowledge of GMP, ICH guidelines, regulatory requirements, and documentation practices.
- Experience with QbD, risk assessment, CPP/CQA and process validation.
- Strong technical report writing and documentation skills.
- Candidates with experience in Parenteral / Injectable Sterile Formulations, Aseptic Manufacturing, Sterile Product Development, and Technology Transfer will also be considered.

📌 Deputy Manager/ Asst Manager R & D/Tech Transfer - Ophthalmic (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai