Research Scientist analyzing and interpreting healthcare data to support specialty value - based programs with Humana. Collaborating with clinical teams to derive actionable insights from complex datasets.
About the role
- Lead Research Scientist overseeing product development and documentation for liquid and injectable formulations at a global health company. Collaborating on innovative medicines at Apotex in Bangalore.
Responsibilities
- To plan and execute the product developmental activities and to ensure proper documentation, follow procedures as per the requirements of Apotex Research Pvt. Ltd.
- Prepare site specific plan for the CMO requirements during batch documentation and ensure the timely execution of projects
- Conduct literature survey and compile the scientific findings
- Plan and perform the Pre-formulation studies, and innovator product characterization
- Planning and execution of product development activities of assigned dosage forms
- Preparation of study protocols and reports, product development report, MFR, SOP, etc.
- Provide necessary inputs and extend support to procure API, raw materials, and packing materials for development batches
- Provide necessary inputs and support for execution of any studies planned in external lab
- Manufacturing of lab scale batches and support to CFT for evaluation of in-process, finished and stability samples
- Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
- Conduct formula and process optimization studies per regulatory standards
- Prepare stability protocols as per regulatory guidelines, execute the studies and compile the results
- Routine calibration of laboratory instruments
- Execution of tech-transfer and monitoring of scale-up/exhibit/process validation batches at plant
- Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting.
- Responsible for tech-transfer of injectable and ophthalmic formulations from R&D to commercial scale
- To ensure smooth technology transfer of products developed at Apotex to CMO
- 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
- Report to next level manager regarding day to day activities.
- Follow departmental SOPs to carryout the product development activities
- Take up any other work as allotted per Department requirements
Requirements
- M Pharma or MS in Pharmaceutics./ Pharma/ B Tech in Pharmacy
- Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
- Effective command over verbal and written communication with good interpersonnel skills.
- Proficient in MS office tools.
- Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc.
- Having well versed knowledge on regulatory guidelines
- Able to priortise the task, best in effective planning of work activities to meet the timelines.
- Must have knowledge on handling of machinery/equipment related to parenteral dosage form
Benefits
- Accommodation for applicants with disabilities as part of its recruitment process
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Principal Scientist leading biopharmaceutical downstream processing in a clinical and commercial environment. Managing a team and collaborating across divisions to support licenses and commercialization.
Associate Principal Scientist in Supply Analytical Sciences responsible for analytical method development and ensuring pharmaceutical product supply. Supporting commercial products in a fast - paced, multidisciplinary team environment.
Postdoctoral Fellow at the Usher Institute focusing on socio - legal aspects of AI. Engaging collaboratively in a multidisciplinary project exploring health and technology in society.
Laboratory Research Assistant conducting data collection for clinical device trials at UHS locations in New York. Responsible for maintaining data integrity and compliance with research protocols.
Senior Applied Scientist leading research and innovations in AI to make legal knowledge accessible at Robin. Bridging gaps between advanced search technologies and legal information needs in a hybrid work environment.
Research Assistant conducting research in pediatrics at Boston Medical Center. Involves patient recruitment, data management, and assisting investigators in preparations.
Research Scientist focusing on developing algorithms and productionizing World Models at Waabi. Join a startup pioneering autonomous transportation technology with a world - class team.
Research Scientist conducting applied research on healthcare data at Phare using AI technologies. Designing experiments and collaborating with MLOps to create measurable impact in the healthcare industry.
Postdoctoral Research Assistant leading analysis of unique datasets on homelessness and health. Join multidisciplinary team at Melbourne Children’s Campus addressing adolescent health challenges.