Research Associate - FD

piramalpharma; Ahmedabad District; On-site; INR 450,000 - 750,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Research Associate - FD to contribute to formulation development for NCE, generic, and line extension products. The role involves literature reviews, process development, and GMP batch manufacturing, with emphasis on documentation and cross-functional collaboration.

Responsibilities include scaling-up, technology transfer, and ensuring compliance with EHS and quality standards across the product lifecycle, including preparation and review of BMR/BPR and

Qualifications

• Experience in formulation development for NCE/generic products.
• Knowledge of BMR, BPR, stability protocols and batch documentation.
• Familiarity with GMP/GDP and EHS requirements in a pharmaceutical setting.

Responsibilities

• Carry out formulation development of NCE, generic, and line extension products.
• Support scale-up, technology transfer, and preparation/review of technical documents (BMR, BPR, stability protocols, deviations, change controls).
• Work in cross-functional teams and maintain EHS and quality compliance throughout product lifecycle.
• Prepare and review QMS documents and participate in departmental audits.

Skills

Formulation development

GxP compliance

Technology transfer

Documentation

Job description

Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

Research Associate - FD Job Description

Carry out formulation development of NCE, generic, and line extension products, including literature review, process development, and GMP batch manufacturing. Support for scale-up, technology transfer, and preparation/review of technical and quality documents such as BMR, BPR, stability protocols, deviations, and change controls in compliance with GxP requirements. Skilled in cross-functional collaboration, client communication, training, equipment management, and ensuring EHS and quality compliance throughout the product lifecycle. Formulation development of NCE projects, generic projects and line extension projects

Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches of assigned product. Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP.

• Representation in departmental audit
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
• Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required.
• Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS
• Communication with cross-functional team and client via mails, meetings and oral communication
• Provide training on but not limited to SOPs, technology, guidelines and project specific activities
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment
• Procuring materials and machines change parts related to concern projects
• Maintain safe and hygienic condition in respective department
• Ensuring the use of personal protective equipment whenever required during batch execution
• Attending training related to FD, EHS, QA or any other department (if applicable)
• Ensure comply with EHS requirements while working in FD lab and Pilot plant.
• Support to proposal preparation for upcoming new projects
• Support to any additional responsibility/activity within or other department as and when required