Executive

SUN PHARMA


Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Job Description

 Designation: Executive/Sr. executive- Protein Characterization

Job Location: Baroda

Department: Proteomics

Job Objective

Searching 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.

Educational Qualification

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

Technical/functional Skills

  • 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.

Experience

  • 2 to 6 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

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