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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.

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Chief Principal Scientist - Technology Transfer