Research Associate - FD

Piramal Pharma Limited; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Limited is a leading CDMO offering end-to-end development and manufacturing solutions across the drug life cycle. The Research Associate - FD role focuses on formulation development of NCEs, generics, and line extensions, with emphasis on GMP batch manufacturing, scale-up, and technology transfer.

You will prepare and review BMR/BPR, stability protocols, and participate in audits, ensuring GxP compliance across projects.

Responsibilities

• Carry out formulation development of NCE, generic, and line extension products.
• Support scale-up, technology transfer, and prepare/review BMR, BPR, stability protocols, deviations and change controls in GxP.
• 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.
• Preparation/review of literature summary and development report for the assigned product.
• 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.

Job description

Be the First to Apply Division Piramal Pharma Solutions

Research Associate - FD

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 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.
• Preparation/review of literature summary and development report to the assigned product.
• 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.