Lead Rsrch Scientist, TchTr-ARPL-RDLD AR

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

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.

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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