POSITION PURPOSE
- The incumbent will be responsible for method development, qualification and validation of various functional methods viz viz Cell Based Bioassays, Metabolic assays, Flow Cytometry based assays, ELISAs and SPR/BIACORE based kinetic assays.
- The candidates will also be responsible for in support of product characterization, in-process, release and stability testing of drug substance and drug product for early-stage biopharmaceutical development programs as well as data package generation for various regulatory filings.
- Will work with cross functional teams to meet project demands and contribute to submissions to regulatory authorities
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsibilities include but not limited to:
Maintaining cell cultures and banking them
Development, qualification and implementation of cell based potency and characterization assays (cell based and non-cell based techniques)
Strictly follow working protocols, SOPs and safe lab practices
Contribute to method transfer and preparation and approval of SOPs, validation protocols and method validation reports; contribute to regulatory filings.
Carry out extensive characterization of reference products to understand requirements of biosimilarity, functionality and potency
Analytical method troubleshooting, optimization, development and validation; summarizing data and writing reports to document findings
Understanding, maintaining and troubleshooting instrument software and hardware
Recording of data in appropriate format and data compilation
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category:R&D
Role:Bio-Technical Research Associate/Scientist
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
Please refer to the Job description above
Education-
UG:B.Sc - Any Specialization, B.Tech/B.E. - Any Specialization
PG:M.Tech - Any Specialization, Bio-Chemistry/Bio-Technology, MS/M.Sc(Science) - Any Specialization, Biotechnology
Company Profile
Mylan Laboratories Limited
Mylan is a global healthcare company focused on making high quality medicines available to everyone who needs them. Our heritage of being a provider of generic pharmaceuticals goes back to our founding in West Virginia in 1961. Today, we are passionate champions for better health around the world with a platform unmatched in the industry.
We have one of the broadest and most diverse portfolios, with more than 7,500 marketed products that include prescription generic and brand-name medicines, and consumer healthcare products. Our healthcare services help patients to access products and adhere to medication regimens to help promote better health outcomes.
We now offer products in more than 165 countries and territories. And depending on the market, our products are distributed through retail channels, by healthcare professionals or in institutional settings.
We have a strong track record of developing new products, particularly complex and difficult-to-formulate medicines. Our approximately 50 plants around the world manufacture tens of billions of doses of medicine annually, and each site adheres to stringent quality standards, regardless of location.
Our most valuable asset is our global workforce, each member of which is a passionate supporter of our cause to deliver better health for a better world
We have one of the broadest and most diverse portfolios, with more than 7,500 marketed products that include prescription generic and brand-name medicines, and consumer healthcare products. Our healthcare services help patients to access products and adhere to medication regimens to help promote better health outcomes.
We now offer products in more than 165 countries and territories. And depending on the market, our products are distributed through retail channels, by healthcare professionals or in institutional settings.
We have a strong track record of developing new products, particularly complex and difficult-to-formulate medicines. Our approximately 50 plants around the world manufacture tens of billions of doses of medicine annually, and each site adheres to stringent quality standards, regardless of location.
Our most valuable asset is our global workforce, each member of which is a passionate supporter of our cause to deliver better health for a better world
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