Piramal Pharma Ltd
Website:
piramalpharma.com
Job details:
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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Assistant General Manager - Packaging Technology
Job Description
The Assistant General Manager – Packaging Development provides strategic, technical, and people leadership for packaging systems, medical devices, and combination products across the entire product lifecycle, from early R&D pipeline to commercial supply.
The role ensures packaging excellence through innovation, regulatory compliance, scalability, cost optimization, sustainability, and organizational capability building, while acting as a key partner to R&D, Manufacturing, Supply Chain, QA, RA , PD&T and Product Development
functions.
- R&D Pipeline & Early‑Stage Product Development Support
- Act as Packaging Development lead for early‑stage R&D pipeline products, ensuring packaging feasibility, manufacturability, and compliance are embedded from concept stage.
- Partner closely with R&D, Formulation, Clinical, and Device teams during molecule selection and development to influence:
- Packaging concepts and platforms
- Container‑closure systems and devices
- Material and technology choices
- Lead early packaging risk assessments (technical, regulatory, supply, usability) to minimize late‑stage redesign and delays.
- Packaging Design & Development
- Lead design and development of packaging systems and medical devices for anesthetic and critical care drug products, including:
- Primary, secondary, and tertiary packaging
- Adaptors, integrated closures, kits, vaporizers, and combination products
- Oversee development of 3D CAD / SolidWorks models, engineering drawings, specifications, and tooling concepts.
- Ensure design for manufacturability (DFM) and effective transfer from development to manufacturing for volatile and non‑volatile liquid products.
- Leverage additive manufacturing and rapid prototyping to support development, feasibility testing, and low‑volume production.
- Design Control, Regulatory & Compliance Leadership
- Ensure full adherence to design control, quality management systems, and global regulatory requirements.
- Oversee creation, maintenance, and governance of:
- Design History Files (DHF)
- Design inputs/outputs, verification and validation protocols & reports
- Risk and criticality assessments
- Lead preparation and review of technical documentation for regulatory submissions (FDA, CE, combination products).
- Support and own primary packaging–related regulatory filings across the product lifecycle.
- Act as Packaging SME and accountable owner during global regulatory inspections and audits.
- Testing, Validation & Patient‑Centric Design
- Own distribution testing, shipping/transportation studies, packaging trials, line trials, and material qualification activities.
- Lead engineering and feasibility studies, including protocol development, execution, analysis, and reporting.
- Ensure packaging designs meet patient safety, usability, child‑resistant, and compliance requirements.
- Lead root cause analysis and implementation of CAPA for packaging‑related deviations, complaints, and quality events.
5. Cross‑Functional & External Leadership
- Serve as senior Packaging Development interface with R&D, Manufacturing, Quality, Regulatory, Supply Chain, Procurement, PD&T, Product Development and Logistics.
- Support internal and external manufacturing sites and CMOs for tech transfer, scale‑up, and operational readiness.
- Lead technical engagements with strategic suppliers, equipment vendors, automation partners, and innovation partners.
- Support onboarding and governance of new suppliers and CMOs, including technical due diligence.
- People Leadership & Capability Building
- Lead, coach, and develop a high‑performing packaging development organization.
- Drive talent development, succession planning, and capability building across technical and leadership competencies.
- Foster a culture of technical excellence, accountability, innovation, and continuous improvement.
- Portfolio, Project & Financial Management
- Govern and prioritize the packaging project portfolio based on business value, risk, and capacity.
- Develop and manage project plans, timelines, budgets, and resource allocation.
- Ensure transparent communication of progress, risks, and mitigation plans to senior stakeholders.
- Standardization, Digital & Continuous Improvement
- Own and drive harmonization and standardization of packaging platforms, materials, and design practices.
- Champion adoption of digital tools, data‑driven design, automation, and future‑ready packaging technologies.
- Institutionalize learnings from pipeline, audits, and post‑market feedback into robust design standards.
9. Sustainability & ESG
- Define and execute a sustainable packaging roadmap aligned with ESG commitments.
- Lead evaluation and adoption of environmentally responsible materials, recyclability, material reduction, and low‑carbon solutions.
- Ensure sustainability initiatives are implemented without compromising patient safety, compliance, or supply reliability.
Packaging TechnologyDesign, Design Controls, Feasibility Studies, Manufacturing, Material Qualification, Packaging, Product Development
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