Scientist II, Bioanalytical Professional

2 weeks ago


Hyderabad, Telangana, India USP Full time

About the Role

We are seeking a highly skilled Scientist II, Bioanalytical to join our team at USP. As a key member of our Bioanalytical team, you will play a critical role in the execution of bioanalytical projects, including the collaborative testing of reference standards and the characterization of biological products.

Responsibilities

  • Plan and execute 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.
  • Prepare project reports as per USP's quality systems and procedures.
  • Demonstrate 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 apply personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory.
  • Comply with USP's Quality Management System and assist group leaders in implementing process improvements.
  • Follow and ensure aspects related to safety, ethics, and legal compliance.
  • Perform duties for the allocated lab/equipment's/inventory/supporting activities and take responsibility for the timely completion of the tasks assigned.
  • Demonstrate a strong desire to continue learning and grow personal capability.
  • Support cross-functional activities in Biologics lab under supervision as per requirement.
  • Assist in quality audits as necessary.

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.
  • Work experience in cGLP/cGMP environment is desirable.
  • Understanding of QMS along with good communication skills is a must.


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