Scientist II, Bioanalytical Specialist

3 weeks ago

Hyderabad, Telangana, India USP Full time

About the Role

This is a hands-on, non-supervisory position in which the incumbent applies their knowledge and practical experience in the execution of bioanalytical projects. The incumbent will collaborate on the testing of reference standards, documentary standards, and the characterization of biological products. Additionally, the incumbent will engage and contribute in verification, international, and national reference standard development programs as assigned.

Key Responsibilities

  • Aligns with USP's mission, goals, and objectives; complies with USP's guidelines and other requirements
  • Plans and executes Compendial projects, verification, R&D projects, and PoC projects under supervision for product classes such as proteins, monoclonal antibodies, peptides, vaccines, and any other biological products as assigned
  • Prepares project reports as per USP's quality systems and procedures
  • Demonstrates strong skills and expertise in Bioanalytical methods in the areas of Chromatography (HPLC/UPLC/nLC), LC-MS, Biochemical assays (SDS-PAGE, Western blot & IEF), and Enzymatic/Protein assays (Spectrophotometer and Plate readers)
  • Routinely applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory
  • Complies with USP's Quality Management System and assists group leaders in implementing process improvements
  • Follows and ensures aspects related to safety, ethics, and legal compliance
  • Performs duties for the allocated lab/equipment's/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned
  • Demonstrates a strong desire to continue learning and grow personal capability
  • Supports cross-functional activities in Biologics lab under supervision as per requirement
  • Assists in quality audits as necessary
  • Performs other duties as assigned

Requirements

  • MSc./M.Tech./M.Pharm. in relevant stream of Biological Sciences with 3-5 years of relevant experience in Analytical R&D/QC department of Biopharmaceutical industry
  • Experience should include strong technical knowledge and practical experience on analytical characterization for biotherapeutics and vaccines using advanced techniques such as Chromatography with PDA/RI/CAD/ELSD etc, Biochemical assays (SDS-PAGE, Western blot, IEF), and Enzymatic/Protein assays (Spectrophotometer and Plate readers)
  • Strong technical background and knowledge on mass spectrometry (MS) qualitative and quantitative studies. Hands-on experience in handling any HRMS instruments and MS relevant sample preparation techniques
  • The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the above-mentioned analytical techniques and should have sound knowledge of QMS systems

Desirable Qualifications

  • Work experience in cGLP/cGMP environment is desirable
  • Understanding of QMS along with good communication skills is a must
  • Good written and verbal communications skills
  • Additional Desired Preferences
  • SEC-MALS or Circular Dichroism or Capillary Electrophoresis instrument handling capabilities
  • Good Presentation skills

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