Job Description

Department Details

Role Summary

Formulation and Development of OSD for Regulated, Semi Regulated and Non Regulated market

Key Responsibilities

Keeps abreast of current trends, practices, developments, and regulatory changes, which would affect products, procedures or formulation.
Execution of experiments timely in meticulous manner.
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.
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.
Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety, or quality.
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 Submit the 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.
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.
Discuss the outcome/status of the developmental trials with the reporting manager for further guidance on product development.
Review the specification and testing methodology of components of drug products prepared by Analytical/Quality Control functions and provide the timely review comments.
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.
Conduct all the relevant studies at R&D to support for the smooth transition of the product across its life-cycle.
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.
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. 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.
Ensure the timely regulatory submission of all the relevant documents and continue with post-filing support for query addressal and technical support; whenever needed.
Comply with all applicable processes and procedures to meet the expectations set forth by all applicable Biocon policies.
Perform all other administrative duties, as assigned.

Educational Qualifications

Required Education Qualification: M.Pharma
Required Experience: 3 - 7 years