Apotex Inc.,
Designation : Scientist
Function : Formulation Development
Functional Area : Injectable, Ophthalmic Formulations
Job Role 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. Â
Job Profile :
- 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 obsevations 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 scalable 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
Job Requirements :
- Minimum 6 to 10+ years of experience in Injectable and Ophthalmic dosage forms in area of Development, Manufacturing and technology transfer expertise for CMO.
- Must have experience in development and tech-transfer of injectable and ophthalmic and complex drug products
- Having well versed knowledge on regulatory guidelines
- Able to priortise the task, best in effective planning of work activities to meet the timelines.
Work / Job Experience : 6-10+ Years
Type of Experience : Development and tech-transfer of injectable and ophthalmic and complex drug products
Academic Qualifications :
- D /M Pharma in Pharmaceutics/B.Pharma.
