Job Summary

To supervise scale-up, exhibit, and process validation batches for successful execution, and ensure the efficient transfer of technology of products developed at Apotex Research Pvt. Ltd. 

Job Responsibilities

• Responsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale
• Gap analysis - To evaluate the product feasibility, technology feasibility at manufacturing site along with gap analysis with available technology for site readiness
• Documentation – Onsite documentation, and timely execution of scaleup, exhibit and validation batches
• Risk assessment – To carry out the risk assessment to identify the impact of critical process parameters and critical material attributes
• To design and review the sampling plan for scaleup, process optimization and submission batches
• To study and verify the parameters established during development are still with in the determined design space in scaleup and exhibit batches
• To coordinate with other departments at plant in completing scaleup and exhibit batch related activities
• In coordination with CMO and PM, ensure the availability of raw materials, packaging materials, filters, tubings etc. required for scale-up, exhibit and commercial batches before initiation of execution
• Compile the batch orsevations and prepare the report of scale-up, EB and commercial/PV batches
• To ensure smooth technology transfer of products developed at Apotex to CMO
• Technical support to formulation development team
• Involve in formulation development activities and assist in development of scaleable manufacturing process
• Review and compilation of the developmental plant scale batches data and stability results
• Coordination with different cross-functional teams like AD, procurement, QA, packing, regulatory affairs, project management 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, Executed BMR, BPR,
• Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
• 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

Job Requirements

• Education
  • D /M Pharma in Pharmaceutics/B.Pharma.
• Knowledge, Skills and Abilities
  • 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.
  • Engage with CMO partners and support the group submission plans
  • 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.
• Experience
  • Minimum 6 to 10+ years of experience in Injectable and Ophthalmic dosage forms in area of Development, Manufacturing and technology transfer expertise for CMO.