Research Associate - FD

Piramal Pharma Ltd; Ahmedabad District; On-site; INR 420,000 - 620,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Research Associate - FD to drive formulation development for NCE and generic projects and to supervise GMP batch manufacturing. The role requires strong cross-functional collaboration, client communication, and training of junior staff while ensuring EHS and quality compliance throughout the product lifecycle.

You will support scale-up, technology transfer to manufacturing sites, and preparation/review of technical documents, with emphasis on GDP and GxP

Qualifications

• Formulation development of NCE and generic projects.
• Prepare and review development reports and literature summaries.
• Supervise GMP batch manufacturing and scale-up activities.
• Prepare/review technical documents (MFC, BMR, BPR, stability protocols).
• Represent the department in audits.
• Ensure GxP compliance and train subordinates.

Responsibilities

• Carry out formulation development of NCE, generic, and line extension products.
• Support scale-up, technology transfer, and documentation such as BMR/BPR and stability protocols.
• Train and guide junior staff; ensure EHS and quality compliance throughout product lifecycle.
• Coordinate with cross-functional teams and clients for project delivery.
• Perform calibration and maintenance of R&D instruments and equipment.

Skills

Cross-functional collaboration

Client communication

Training

Equipment management

GxP compliance

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
• 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