Biocon Biologics at Chennai is a 56000 sq. ft RND centre equipped with end-to-end cutting-edge infrastructure involving upstream, downstream, formulation, analytical characterization, functional characterization, and pilot facilities. A world-class team is being put together to develop biosimilar therapies all the way through process development, characterization, scale-up, and technology transfer to feed into our large-scale manufacturing facilities at Bangalore. We are looking for passionate science-driven minds at all levels across different functions.
Post : Associate Scientific Manager I
Role Summary
Formulation research and development of solid oral dosage forms
Job Description :
• Keeps abreast of current trends, practices, developments, and regulatory changes, which would affect products, procedures or formulation.
• Complete documentation of the experiments, results and discussion on way forward with superiors.
• Constructs experimental studies intended to provide supporting data or to resolve technical issues encountered during a project.
• Conduct the thorough literature search on the assigned projects by gathering information and data available in the public domain.
• Perform the preliminary evaluation of drug substances and excipients by collecting the relevant data.
• Conduct the development trials with appropriate guidance from the reporting manager and submission of development samples for analysis and load the samples for stability, wherever applicable.
• Document all the activities as per the applicable principles of Data Integrity and Comply with the requirements of all the applicable SOP/IOP/EOP procedures.
• Participate, engage and present the compiled data to all the relevant stakeholders during the product review meeting that ensures the knowledge transfer to all the critical stakeholders thereby supporting a sound decision-making.
• Compile and compare the data of large-scale batch with the developmental data for ensuring the robustness of the product manufacturing at the commercial scale.
• Prepare the product development report by thoroughly capturing all the relevant data in a detailed yet concise manner ensuring the technical adequacy and completeness.
• To follow the approved standard procedures, corporate procedures, company policies and GXP practices.
• Designing, implementing & strengthening pharmaceutical quality system at R&D and Developing and driving continuous improvement initiatives.
• Co-ordinate with relevant functions like Project Management, Regulatory, Technology Transfer, Operations, Productions, Quality and Regulatory to ensure that the projects are planned and executed in a timely manner.
• Assist in resolving technical issues and drive the completion of investigations that affect the technical scope, makes recommendations for various options that would resolve the issue.
• Ensures the maintenance and/or adherence to good laboratory practices and all safety regulations in manufacturing areas.
• Discuss the outcome/status of the developmental trials with the reporting manager for further guidance on product development.
• Co-ordinate with Analytical function for the analytical reports of the submitted samples and compile the developmental data that effectively reflects the trials undertaken and corelate with the critical quality attributes of the drug product.
• Conduct all the relevant studies at R&D to support for the smooth transition of the product across its lifecycle.
• Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety, or quality and maintaining of current training records for required procedures.
• Prepare the necessary manufacturing documents for executing the batches at manufacturing plant and co-ordinate with relevant stakeholders in understanding and addressing the technical queries on the drug product.
• Monitor and Support the batch manufacturing at larger scale to gain the understanding on the product and process.
• Perform all other duties, as assigned by reporting manager.
Additional Information
Experience : 5-10 years
Qualification : M.Pharm
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GENERIC FORMULATION R&D
Requisition ID : 9545
End Date : 20th November, 2022
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