Lead Research Scientist – Technology Transfer

Role Overview

• Responsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale
• To evaluate product and technology feasibility at manufacturing site along with gap analysis
• Onsite documentation, and timely execution of scaleup, exhibit and validation batches
• Carry out risk assessment to identify the impact of critical process parameters and critical material attributes
• Design and review sampling plans for scaleup, process optimization and submission batches
• Verify parameters established during development are within determined design space in scaleup and exhibit batches
• Coordinate with other departments at plant in completing scaleup and exhibit batch related activities
• Ensure availability of raw materials, packaging materials, filters, tubings etc. required for scale-up, exhibit and commercial batches before initiation of execution
• Compile batch observations and prepare reports of scale-up, EB and commercial/PV batches
• Ensure smooth technology transfer of products developed at Apotex to CMO
• Provide technical support to formulation development team
• Involve in formulation development activities and assist in development of scaleable manufacturing process
• Review and compilation of developmental plant scale batches data and stability results
• Coordination with different cross-functional teams for smooth execution of scale-up batches
• Coordination with external labs for successful completion and receipt of studies data performed for plant scale batches
• Review of MFR, BMR, BPR, stability protocols, study protocols and reports
• Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting
• Report to next level manager regarding day to day activities.
• Preparation of SOPs and ensure compliance as per SOP
• Take up any other work as allotted

Requirements

• D /M Pharma in Pharmaceutics/B.Pharma
• Must have experience in development and tech-transfer of injectable and ophthalmic and complex drug products
• Effective command over verbal and written communication with good interpersonnel skills.
• Proficient in MS office and advanced software tools.
• Having well versed knowledge on regulatory guidelines
• Able to priortise the task, best in effective planning of work activities to meet the timelines.
• Minimum 6 to 10+ years of experience in Injectable and Ophthalmic dosage forms in area of Development, Manufacturing and technology transfer expertise for CMO.

Benefits

• Accommodation for applicants with disabilities as part of recruitment process