- 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-
- Responsible 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.
- M.SC. in Biochemistry / Life Sciences / Biotechnology.
- 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.
- 2 to 4 years of relevant industrial experience
- Highest emphasis on Ethics and Data Integrity
- Commitment to maintaining Safe work practices and Safety compliant Behaviour at workplace
- Commitment to Quality, Compliance, Efficiency, Cost, On-Time Delivery
- Effective Communications skills (verbal and written) is desirable.
- Proactive nature with excellent interpersonal skills to build and maintain professional working relations
- Ability to handle cross-functional requirements.
- Work collaboratively with other team members in an effective and cordial manner
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Senior Executive - Vadodara, India - SUN PHARMA
Description
JOB DESCRIPTION
Designation: Executive/Sr. Executive In process analytics
Job Location: Baroda
Department: Proteomics
Job Objective
Searching for highly motivated candidate having technical expertise in Biosimilar product analysis.
Key Responsibilities:
Educational Qualification:
Technical/functional Skills:
Experience:
Behavioral Skills: