Job Description

JOB DESCRIPTIONDesignation: Executive/Sr. executive- Protein CharacterizationJob Location: BarodaDepartment: ProteomicsJob ObjectiveSearching for highly motivated candidate having technical expertise in Biosimilar product characterization.Key Responsibilities:

• The candidate is expected to develop LC-MS based methods for protein and peptide product characterization.
• The candidate is expected to qualify the methods for intended purpose for all pipeline products.
• The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile.
• Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc.
• 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.
• The candidate is responsible for the operation and maintenance of the MS instruments
• To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues.
• Responsible for managing the regulatory queries.
• The candidate is expected to draft the technical content for regulatory dossier.

• M.SC./M.Tech in Biochemistry / Life Sciences / Biotechnology.

• Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins.
• Experience of biosimilarity assessment of biologics for regulated market is desirable.
• Experience of analytical development for monoclonal antibodies and fusion proteins and peptide is highly desirable.

• 2 to 6 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

Sun Pharmaceutical Industries