Role & responsibilities To lead the OSD department team and ensure manufacturing process development and Optimization as per the regulatory requirements & technology transfer of the projects in co-ordination with Production and planning department for regulatory & ROW products. Accountabilities and mandatory requirements: Ensure composition and manufacturing process development of new as well as established products and ability to improvise if needed. Ensure manufacturing process/new process within Budget for maximizing efficiencies of Formulation Department Lab. Guide group for day-to-day activities and informing Formulation Development Department (FRD) colleagues for the schedule and timelines for the product development as well as technology transfer of Exhibit, Validation or commercial batches. Ensure group co-ordinate with other functions including Purchase, Production for the status of availability of Raw Materials, Packaging Materials required for development batches/ exhibit batches/ Validation batches at site. Ensure development and stability data generation of the new as well as trouble shooting products as per the regulatory or ROW market requirements. Guide to the for encounter the trouble shooting of legacy products and to provide the Technology transfer documents to resolve or to overcome issues related to the legacy products to provide quality products to the customer. Guide group for the smooth technology transfer of new as well as existing products or trouble shoot products for better to meet the finished product specification. Ensure the Regulatory queries to be addressed in time and guide the group leaders to work on to provide comments on the received quires to be close within provided timeline. Work closely with cross functional team for planning /execution of the Technology transfer/Exhibit/Validation batches of the individual projects to meet the timelines assigned. Provide the technical oversight (guidance), Plan, co-ordinate and oversee the work activities related to technology transfer/Exhibit batches/Validation batches of projects not limited to EU authorization but also CMO/ROW projects. Ensure Compilation of Development batches/Exhibit batches/validation batches data included with critical observations and submission of the same to R&D Head. Co-ordinate with production department for planning of tech transfer /Exhibit/Validation batches and execution/monitoring of the batches of the products starting from dispensing of the materials till packaging of the product to ensure smooth technology transfer of the products complying to the regulatory requirements. Preferred candidate profile- - 8-12 years of experience in Regulated market- OSD formulation & Development and technology transfer. - Good communication, open exchange of information and project teamwork will be required in order to meet the job performance. - Will be expected to accomplish his work assignments by interacting closely with scientific staff/Production staff and by developing the co-operative working relationships with other personnel within the company. - Must be able to work/co-ordinate with different functions within ALS and prioritize the workload to meet the predetermined timelines and need to work as a team with open communication, transparency and mutual trust. - Proper documentation pertaining to Formulation Development as per the Regulatory requirements and as per companys system.

Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.

RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updating in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Technically sound in development of Injectable/ Oral solid products and semisolid and liquid dosage forms. If additional knowledge of regulatory documents preparation is essential

Role & responsibilities Literature Survey for the assigned project. Analytical method development such as Assay, Dissolution, Related Substances method by HPLC. Analytical method validation of Assay, Dissolution, Related Substances method by HPLC as per ICH guideline by HPLC. 4. Analysis of Initial and stability samples. 5. Carry out basic trouble shooting for instrument related issues, whenever required. Email id- namita.raul@ashishlifescience.com