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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
Chief Principal Scientist - Technology Transfer
Job Description
The role holder will assist with Pharmaceutical Research and Development and the Technology Transfer of Injectable Drug Products, working on both manual and automated platforms while ensuring high quality within the designated timeframe. This role will additionally support Manager in Lab/ CMO/CRO and EHS management.
Business: Piramal Critical Care
Department: Business Development
Location: Rabale
Travel: High
Key Responsibilities
Tech transfer Formulation
- Execute smooth technology Transfer and or Scale-up of acquired or developed formulation products into and out of company
- Work with third party agencies for development and validation.
- Support in preparation, technical evaluation of RFP, Customer Visits and Product Testing.
- Prepare and review documents related to technology transfer such as protocols, BMR, reports, TTD and PDR, formulation related SOP's i.e. instruction manuals.
- Interact and support cross functional team such RA, QA, micro and clients
- Research, design and evaluate materials, assemblies, processes and equipment.
Pharmaceutical development for new or identified product
- Develop Plan, coordinate and manage /execute laboratory pharmaceutical development activities in coordination with team members.
- Show pharmaceutics proficiency and use advanced analytical techniques to develop drug product.
- Perform complex experimental tasks including new techniques, procedures and equipment and propose experimental program and discuss with manager.
- Prepare project budget and schedule, proposals by collaborating with other stake holders. Track project progress periodically and achieve project goals.
Business support
- Troubleshoot & or improve existing processes at the manufacturing sites
- Understand customer expectations on to-be manufactured product.
- Research, evaluate and assess feasibility of projects and provide feed back
- Acquire and document existing and elaborated knowledge.
Compliance and admin
- Develop, maintain, manage and document all research materials and data
- Maintain inventory control of laboratory equipment and tools.
- Interact with accounting department in processing payments.
- Comply with regulations concerning safety, health and environment
- Make presentation – Work Status updates to internal or external clients.
- Support lab leader for project reviews, presentations, scientific reports preparations, literature search and analysis
People management
- Instruct, supervise and coach less experienced lab team members on assigned tasks and EHS issues
- Provide assistance and conduct trainings to team members when needed.
Key Competencies
- Knowledge of Pre-formulation, Formulation Process Development for Europe, US & Japan market as well as for Domestic.
- Well versed with Optimisation and Trouble Shooting using QbD Approach, Risk assessment
- Preparation and review of – MFR, MPR, BMR, BPR, Reference formula document, Product Development Report and relevant SOPs.
- Liaison & Coordination - CRO & CMO Handling is must for tech transfer of products.
- Knowledge Reverse Engineering, PARA IV filing
- Project Management (from initiation to commercial Production)
- Technical communication
- Knowledge of plant operations, and quality systems, ICH guideline, GLP & GMP with Desired knowledge of QA & Regulatory functions.
- Very good ability to interpret data, draw conclusions, and present results. Sound Knowledge regarding formulation patents and patent issues
- Technical writing skills. MS Office (Word, Excel & PowerPoint), Chemdraw and Internet Applications.
- Knowledge of SAP and other sourcing tools.
- Team Building & Leadership, R&D Lab set up, Equipment's, Qualifications. (DQ, IQ, OQ & PQ)
Education And Relevant Experience
- Masters in Pharmacy
- Strong Knowledge and understanding of the Pharmaceutical development and technology transfer with 12 - 15 years of industrial experience specially in sterile injectable products.
