Senior Research Associate -FD

Piramal Pharma Limited; India; On-site; INR 550,000 - 850,000; Full time

Job summary

Piramal Pharma Limited, a leading contract development and manufacturing organization, invites applications for a Senior Research Associate - FD. The role focuses on formulation development, GMP-compliant manufacturing, and executing NCE and generic projects using QbD principles.

The incumbent will prepare and review literature, development reports, and GMP documentation, while ensuring GxP compliance, training subordinates, and participating in audits and cross-functional collaborations across

Responsibilities

• Delivery of project within timelines, cost and specifications.
• Formulation development and manufacture of solid oral and other dosage form.
• Execution of NCE projects, generic projects and line extension projects using QbD principle.
• Preparation and/or 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 to the assigned product.
• Preparation and/or review of technical documents like MFC, BMR, BPR and Stability protocol etc. following the GDP.
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up and pilot batches in pilot under GMP condition.
• Preparation and/or review of technical documents like product development report, batch manufacturing record, technology transfer documents and transfer of technology to manufacturing site, if required.
• Preparing/reviewing/approving the QMS documents like change control, deviation and out of specification.
• Communicating with cross-functional team and client via mails and meetings.
• Participating and representing in departmental audit.
• Preparing and reviewing department relevant SOPs.
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment.
• Procuring/ indenting 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 and QA (if applicable).
• All generated waste to be sent to concerned person and must be comply with EHS requirements.
• Communicating and interacting with international and national clients.
• Preparing and/or reviewing of proposals for upcoming new projects.
• Annual performance review and goal setting of team members.
• Any other task or assignments given related to project by management or organization for product development and organization improvement.

Job description

Be the First to Apply 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

Senior Research Associate -FD

Job Description

• Delivery of project within timelines, cost and specifications.
• Formulation development and manufacture of solid oral and other dosage form.
• Execution of NCE projects, generic projects and line extension projects using QbD principle.
• Preparation and/or 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 to the assigned product.
• Preparation and/or review of technical documents like MFC, BMR, BPR and Stability protocol etc. following the GDP.
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up and pilot batches in pilot under GMP condition.
• Preparation and/or review of technical documents like product development report, batch manufacturing record, technology transfer documents and transfer of technology to manufacturing site, if required.
• Preparing/reviewing/approving the QMS documents like change control, deviation and out of specification.
• Communicating with cross-functional team and client via mails and meetings.
• Participating and representing in departmental audit.
• Preparing and reviewing department relevant SOPs.
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment.
• Procuring/ indenting 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 and QA (if applicable).
• All generated waste to be sent to concerned person and must be comply with EHS requirements.
• Communicating and interacting with international and national clients.
• Preparing and/or reviewing of proposals for upcoming new projects.
• Annual performance review and goal setting of team members.
• Any other task or assignments given related to project by management or organization for product development and organization improvement.

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.