Research Associate- Analytical

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Division

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

Job Description

Area of Responsibility

Analytical development for new or identified product 
(API/formulation/Speciality chemicals)

• Under general supervision of lab team leader or R & D Manager, independently perform routine scientific research tasks using standard techniques, procedures and equipment.

• Execute experimental plans, support in investigate technical concepts & needs, 

• Perform Analytical Method development and validation under supervision of reporting manager for API and Formulation products, raw materials, excipients using analytical techniques such as HPLC, GC, etc. literature search.

• Support in performing  Analytical method transfer for Formulation project at manufacturing site. On-line troubleshooting as well as during method development & method transfer.

• Support routine analysis. Experimental data generation,  interpretation and review for API & formulation analytical development.

• Interface with organizational departments in analytical method  transfer of new products technology 

• propose experimental program and discuss with manager/R&D engineers 

• Show analytical chemistry proficiency and use advanced analytical techniques to develop analytical testing methods for new product.

Business support

• Providing timely support to plant / Regulatory or QA in resolving analytical related queries,

• Analyse and support in resolving research issues in a timely and accurate manner. 

Compliance and admin

• Analysis of development batches and routine stability samples.

• Preparation of standard test procedure, SOP,IOP 

• Follow cGMP compliance practices in the lab. 

• Coordination with all interfaces for the support in successful product development.

• Responsible for maintenance of assigned laboratory section and lab work as per CGLP requirement.

• Perform general lab assignments e.g. analytical reagents and columns inventory management, Calibration of analytical instruments, Maintaining IQ/ OQ/ PQ documentation for analytical instruments, lab house-keeping, Implementation of SOP in R&D Lab,  Updating/ Renewal of Annual Maintenance Contract for analytical instrument, as assigned.  

People management

• Cordinate with team members on assigned tasks and EHS issues

Tech transfer

• Provide onsite or offsite support for execution of transfer activity as per Plan 

• Support in preparation,for Analytical method transfer documents such as Method assessment document, Analytical method transfer plan, Protocol and Reports, stability data etc.

Education Qualification

• M.Sc. ( Chemistry or its related functionary)

Minimum Experience (in Years)

• 0-4 years 

Key Competency

• Technical & Professional Knowledge

  • Strong Knowledge and understanding of the analytical chemistry, various analytical technique used  with  industrial experience.

  • Experience of using various analytical instruments Like HPLC, GC, IR, Auto titrator, 

  • Basic understanding of analytical method development, validation and transfer.

  • well versed with HPLC, GC, and other sophisiticated instruments

• Knowledge QMS, ICH guideline,& cGMP 

• Ability to  interpret data, draw conclusions, and present results.

• Technical writing skills. MS Office (Word, Excel & PowerPoint) and Internet Applications.