Senior Research Scientist in GMP laboratory developing high - quality injectable medicines. Seeking motivated individuals to join R&D team committed to improving patient health.
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
Application Scientist in AQEMIA's Molecular Simulations Team focusing on molecular modelling and drug discovery. Collaborating with diverse teams to guide the development of high - potential drug candidates.
Senior Researcher managing quantitative social surveys at NatCen, liaising with clients and collaborators. Contributing to research design, implementation, and analysis.
Chargé de recherche - Post - doctorant developing a bio - inspired decision support tool for zero carbon energy mix at UniLaSalle in Amiens.
Senior Research Scientist developing AI systems for speech and language, collaborating with research teams and mentoring interns. Working on Deep Learning models for NLP and ASR at NVIDIA.
Research Assistant working on an MRC - funded project investigating PFKFB3's role in metabolic dysfunction and liver cancer biology at Newcastle University.
Principal Scientist leading product development for Kraft Heinz’s Canada portfolio. Collaborating with cross - functional teams to commercialize projects in a fast - paced environment.
Data Scientist collaborating with teams to optimize machine learning for advertising. Building and deploying models for campaign performance across e - commerce and social commerce platforms.
Postdoctoral Research Fellow focusing on agentic AI systems at Mitsubishi Electric Research Laboratories. Engaging in independent research and collaborating with teams to publish findings.
Research Scientist specializing in optimization algorithms for electric grids, drones, transportation, and supply chain management. Aiming to impact the scientific community and Mitsubishi Electric's future technology.