Scientist II, Bioanalytical

1 week ago

Hyderabad, India USP Full time

Description

Brief Job Overview

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

How will YOU create impact here at USP?

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 project 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

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

Who USP is Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

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

· Good written and verbal communications skills

Additional Desired Preferences

· SEC-MALS or Circular Dichroism or Capillary Electrophoresis instrument handling capabilities

· Good Presentation skills

Supervisory Responsibilities None Benefits USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected. COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired): As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

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