Deputy Manager/ Asst Manager R & D/Tech Transfer - Ophthalmic

Navlakha Management Services; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Navlakha Management Services is seeking an experienced Deputy Manager / Assistant Manager R&D / Technology Transfer for ophthalmic formulations in Mumbai. You will oversee development, scale-up, and technology transfer, coordinating across R&D, manufacturing, QA, and regulatory teams to ensure smooth transfer to commercial production.

The role requires 7–15 years in pharma R&D/Technology Transfer with a strong background in sterile ophthalmic products, GMP, QbD, and DoE.

Qualifications

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 CPPs and 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 new 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.

Job description

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 new 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.