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Senior Executive

1 month ago

Vadodara, India SUN PHARMA Full time
JOB DESCRIPTION

Designation: Executive/Sr. Executive In process analyticsJob Location: BarodaDepartment: ProteomicsJob ObjectiveSearching for highly motivated candidate having technical expertise in Biosimilar product analysis.Key Responsibilities:The candidate is expected to develop HPLC based methods for protein and peptide products.The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on RP-HPLC, SEC-HPLC, CEX-HPLC..etcResponsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable.The candidate is expected to qualify the methods for intended purpose for all pipeline products.Responsible for routine in process sample analysis.Responsible for preparation and review of method development reports (MDR) and analytical test procedures (ATP).Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations.Responsible for managing the regulatory queries.The candidate is expected to draft the technical content for regulatory dossier.Educational Qualification:M.SC. in Biochemistry / Life Sciences / Biotechnology.Technical/functional Skills:Sound knowledge of analytical method development, qualification.Experience in biosimilar development for regulated market is desirable.Experience of analytical development for monoclonal antibodies and peptide is highly desirable.Experience:2 to 4 years of relevant industrial experienceBehavioral Skills:Highest emphasis on Ethics and Data IntegrityCommitment to maintaining Safe work practices and Safety compliant Behaviour at workplaceCommitment to Quality, Compliance, Efficiency, Cost, On-Time DeliveryEffective Communications skills (verbal and written) is desirable.Proactive nature with excellent interpersonal skills to build and maintain professional working relationsAbility to handle cross-functional requirements.Work collaboratively with other team members in an effective and cordial manner

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