Senior Officer

Formulation Development:Formulation and devlopment of Injection/Parenteral formulations (US/EU/ROW/Domestic/NDDS …) for assigned products.Conduct research to develop new formulations for pharmaceuticals, cosmetics, or other products.Optimize existing formulations to improve product stability, efficacy, and manufacturability.
Experimental Design and Execution:Design and execute experiments to test and evaluate different formulation strategies.Analyze experimental data and draw conclusions to inform further development.Conducting developmental trials /feasibility studies / Pre formulation studies /reformulation trials under product development as per the instruction given by Group leader.Perform related activity/Trials for market complains, regulatory queries or IPR  Innovator/ Market samples study as per the SOP/Instructions.Withdrawing the samples from Stability chamber as per timeline & sending for analysis to ADL department.Indenting of RM/PM/API for devlopment supportStability samples & RLD/Market sample magmement (loading/withdwal and sent for analysi)Handling, Maintain documentation related to usage and testing of Narcotic/Psycotropic or controlled substances as per Gudieline if any.
Literature Review:Stay current with scientific literature and industry trends related to formulation development.Apply relevant findings to enhance the organization's formulation strategies.Literature search related to patent, Pharmacopoeial and research articles for F&D trials.
Departmental activitiesMaintenance activity of parenteral section/area (Lyophilizer, ampoule filling m/c, pH meter, DO meter etc.)Work closely with analytical scientists to ensure accurate and meaningful data interpretation.Stock verification in SAP and placing requisitions for various materials required in F&D from production store (Dun & Thol)Verification of Weighing balance and calibration of pH meter
Documentation:Maintain detailed and accurate records of experimental procedures, results, and observations.Prepare technical reports, summaries, and documentation for internal use and regulatory submissions.Maintain the machine log book for relevant machine & equipment.Documenting and Reporting the observations for the F&D trials.Preparation, writing & maintaining of Lab note book & PDS for the F&D trials.Preparation of the  PDS, MCM, PDR, CMC and Technology transfer documents (Code generation, Spec generation, PDS, PDR, QTPP and CQA etc) and query base document as per regulatory requirement and raising the CCF document/Product ID form for new product as on site specific.PDR preparation as per regulatory requirements 
Collaboration:Collaborate with cross-functional teams, including ADL scinetiest,  engineers team, and manufacturing professionals, to integrate formulation efforts into the broader product development process.
Problem Solving:Identify and troubleshoot issues related to formulation development.Propose and implement solutions to overcome challenges and optimize formulations.
Regulatory Compliance:Ensure that all formulation development activities comply with relevant regulatory requirements.Contribute to the preparation of documents for regulatory submissions.
Scale-up Support:Provide support for the scale-up of formulations from laboratory to pilot or manufacturing scale. Coordinate and involve in taking PV/TT batches in praposed plant location Collaborate with process development teams to ensure seamless transition.
Safety and Compliance:Adhere to safety protocols and guidelines in the laboratory.Ensure compliance with Good Laboratory Practices (GLP) and other relevant quality standards.
Training and Development:Stay informed about new technologies and methodologies in formulation development.Contribute to the training and development of junior staff members.
Communication:Effectively communicate findings and progress to project teams, management, and other stakeholders.Participate in internal and external meetings, presenting data and updates whenever asked.Communication with maintenance department in case of any break down of machine.
Note: Job description as mentioned above are not limited; it may vary based on management & organization requirements.

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