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Opportunity for Senior Research Scientist in Product Development at Sentiss Pharma

 

Clinical courses

Established in the early 90's, this organization has emerged as an integrated pharmaceutical company offering products to the global market. Headquartered at Delhi NCR, India and plant in North India, the Company develops, manufactures and markets a wide range of quality products in diverse area of treatment.Over the years, the organization has positioned itself as a significant player in the Russian and CIS markets and has expanded its foothold in the US, Europe, India and other markets. The key competitive advantage lies in having the Research & Development centre together with the world class manufacturing facility that has enabled it to provide end-to-end solutions from product development to marketing. The manufacturing facilities are approved by many regulatory bodies including EUGMP and WHOGMP thereby allowing the company to reach International markets.

Post : Senior Research Scientist - Product Development

Project initiation activities:-
To perform literature search required for idea generation form (IGF) upon receiving IGF
To review DMF received from suppliers
To prepare product feasibility based on IGF received
To create the item codes for material and procure material and Reference Listed Drug (RLD)
To assist AD lab for Q1 Q2 estimation of RLD
To draft tentative specification for API, RM and finished good
To plan laboratory trials and stability batches
To finalize proposed manufacturing process
To initiate filter validation process with the filter supplier

 

Documentation:-
To prepare tech transfer documents including MFR, BOM, Process flowchart, Critical process parameters and critical quality activities
To review product specifications, manufacturing documents
To prepare documents for trial batches
To prepare product development report
To prepare and review SOPs and prepare response for internal audits
To review documents related to filter validation
Product Specification/ Tech Transfer/ Commercialization
To organize and execute trial pre exhibit and exhibit batches at plant
To execute first three commercial batches at plant
To provide technical support for existing commercial batch
To perform investigation of failures during exhibit batches/ stability (Out of Specification)
Innovation
As a stretch target come up with innovative and patentable formulations proposals or novel ideas which can reduce workload or expenses

Additional Information:
Experience: 4 - 6 Years
Location: Gurgaon
Education: M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: R&D
End Date: 30th November, 2017

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