Manager - TSD

Piramal Pharma Limited; Digwal; Vor Ort; INR 3.500.000 - 4.500.000; Vollzeit

Zusammenfassung

Piramal Pharma Limited, a global CDMO, seeks a Process Engineer / Technology Transfer Manager to drive tech transfer from R&D to pilot and commercial manufacturing. You will execute pilot campaigns, scale-up activities, and ensure regulatory compliance across production stages.

The role requires strong process engineering knowledge, problem-solving skills, and the ability to coordinate with R&D, Production, QA, and other teams to transfer and commercialize manufacturing processes.

Qualifikationen

• Strong process engineering knowledge and problem-solving skills.
• Ability to collaborate with cross-functional teams to transfer and commercialize manufacturing processes.

Aufgaben

• Execute technology transfer activities from R&D to pilot plant and commercial manufacturing.
• Evaluate process feasibility for scale-up.
• Plan and execute pilot plant campaigns, engineering batches, trial batches, and process validation batches.
• Perform process scale-up activities while ensuring product quality, process safety, and regulatory compliance.
• Coordinate with R&D, Production, QA, QC, Engineering, EHS and Supply Chain teams to ensure successful project execution.
• Review GMP documentation including BMRs, SOPs, and transfer documents.

Jobbeschreibung

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 Manager - TSD

Job Description We are seeking a Process Engineer / Technology Transfer Manager to support technology transfer, process scale-up, and commercial manufacturing of pharmaceutical/API products. The role involves executing pilot plant, validation, and commercial batches, optimizing manufacturing processes, providing technical support for production, review engineering documentation, participating in HAZOP and process risk assessments, and ensuring compliance with cGMP requirements. The ideal candidate should possess strong process engineering knowledge, problem-solving skills, and the ability to collaborate effectively with cross-functional teams to successfully transfer and commercialize manufacturing processes.

Process Engineer / Technology Transfer Manager

• Execute technology transfer activities from R&D to pilot plant and commercial manufacturing.
• Evaluate process feasibility for scale-up.
• Plan and execute pilot plant campaigns, engineering batches, trial batches, and process validation batches.
• Perform process scale-up activities while ensuring product quality, process safety, and regulatory compliance.
• Provide technical support for troubleshooting and process optimization.
• Review Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), and process mapping documents.
• Conduct HAZOP studies and participate in process risk assessments to identify and mitigate operational hazards.
• Evaluate process performance, identify bottlenecks, and implement continuous improvement initiatives.
• Review GMP-compliant documentation, including Batch Manufacturing Records (BMRs), SOPs, and technology transfer documents.
• Investigate manufacturing deviations, perform root cause analysis, and prepare investigation reports with appropriate CAPA recommendations.
• Manage Engineering Change Requests (ECRs) and support change control implementation.
• Coordinate with R&D, Production, Quality Assurance, Quality Control, Engineering, EHS, and Supply Chain teams to ensure successful project execution.
• Ensure compliance with cGMP, quality systems, process safety, and regulatory requirements throughout the product lifecycle.
• Support process validation, equipment qualification, and commercial manufacturing activities.
• Participate in continuous process improvement, cost optimization, and manufacturing efficiency enhancement initiatives.

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.