Title:  Senior Executive

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: 

• 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..etc

• 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.

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 experience

Behavioral Skills:

• 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