US Pharmacopeial Convention Scientist II BioAnalytical Recruitment, Apply Online

US Pharmacopeial Convention Scientist II BioAnalytical Recruitment, Apply Online. Biological Sciences Jobs. MSc & MTech Jobs. Interested and eligible applicants can check out all of the details on the same below

If you are considering applying for the role of Scientist II BioAnalytical at U.S. Pharmacopeial Convention then check out all of the possible interview questions below

Name of the Post – Scientist II BioAnalytical

Location – Hyderabad, India

Description

Brief Job Overview

This is a hands-on position in USP-India’s Biologics laboratory in which the incumbent is responsible for delivering laboratory projects by independently contributing in execution of laboratory experiments, project documentation and managing laboratory activities. Deep domain scientific knowledge and laboratory experience in analysis of Biologics is required to contribute in development of reference standards, documentary standards and new initiatives for Biologics product classes such as therapeutic proteins, monoclonal antibodies, vaccines, and peptides using USP’s standard setting processes.

How will YOU create impact here at USP?

• Aligns with USP’s mission, goals and objectives and complies with USP’s guidelines and other requirements.
• Demonstrates laboratory skills and hands on expertise in analytical Chromatography (HPLC/UPLC with PDA/IR/FLR etc, Ion-chromatography), Electrophoresis, Biochemical assays (SDS-PAGE, Western blot, IEF) and Enzymatic/Protein assays (Spectrophotometer and Plate readers).
• Plans and executes Compendial and R&D projects besides contributing in the new initiatives , proof of concept studies in Biologics for product classes such as proteins, enzymes, vaccines, monoclonal antibodies, peptides, antibiotics, and any other biological products as assigned.
• Evaluates and analyzes scientific reports, applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory within the scope.
• Performs administrative responsibilities, mentors and trains team member/members as assigned.
• Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
• Prepares and reviews project reports, SOPs, and other documents to ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits
• Assists and recommends improvements in laboratory/project management methods and processes.
• 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 4-6 years of industry experience working in Analytical R&D/QC department of Biopharmaceutical industry.
• Practical hands-on experience on analytical characterization for biotherapeutics and vaccines using advanced techniques such as Chromatography with multiple detectors, Capillary Electrophoresis (SCIEX/Maurice), Biochemical assays (SDS-PAGE, Western blot, IEF) and Enzymatic/Protein assays (Spectrophotometer and Plate readers).
• 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.
• The candidate should have strong competencies in technical writing, communication, and presentation skills.

Additional Desired Preferences

• Experience in other advanced analytical techniques such as Mass spectrometry, Circular dichroism, MALS, Differential scanning calorimetry would be an advantage.
• Previous experience working in biopharma cGLP/cGMP/QMS environment with practical experience in good documentation practices and knowledge on biopharmaceutical reference standards is a plus.

Supervisory Responsibilities

• Nil

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.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

APPLY ONLINE

Here is a list of possible interview questions for the role of Scientist II at U.S. Pharmacopeial Convention below

1. Can you describe your experience and expertise in analytical chromatography techniques such as HPLC/UPLC with PDA/IR/FLR and Ion-chromatography? Provide examples of projects where you have applied these techniques.
   • Answer: During my industry experience, I have worked extensively with HPLC/UPLC using various detectors like PDA, IR, and FLR. I have also utilized Ion-chromatography for specific analyses. For instance, I successfully developed a method using HPLC-PDA to analyze protein impurities in a therapeutic protein formulation, ensuring high product quality and safety.
2. How familiar are you with analytical characterization techniques for biotherapeutics and vaccines, such as SDS-PAGE, Western blot, IEF, and enzymatic/protein assays? Share your practical experience in applying these techniques.
   • Answer: I have hands-on experience with SDS-PAGE, Western blot, IEF, and enzymatic/protein assays for characterizing biotherapeutics and vaccines. In one project, I utilized Western blotting to confirm the presence of specific antigens in a vaccine formulation, ensuring its potency and efficacy.
3. Can you discuss your experience in working with QMS systems and your knowledge of good documentation practices? How have you ensured compliance to quality management systems in your previous role?
   • Answer: In my previous role, I have been responsible for adhering to QMS systems and maintaining good documentation practices. I have actively participated in internal and external audits to ensure compliance with ISO 9001 and ISO 17025 standards. By implementing robust document control procedures and conducting regular training sessions, I have contributed to maintaining high-quality standards in our laboratory.
4. Have you worked with advanced analytical techniques like mass spectrometry, circular dichroism, MALS, or differential scanning calorimetry? If so, please provide examples of projects where you have utilized these techniques and the insights gained.
   • Answer: Although my primary focus has been on chromatography and biochemical assays, I have some exposure to mass spectrometry and circular dichroism techniques. In a recent project, I employed mass spectrometry to identify and quantify protein modifications in a biopharmaceutical product, providing valuable insights into its stability and quality.
5. How have you demonstrated effective communication and technical writing skills in your previous roles? Give examples of reports, SOPs, or other documents you have prepared to ensure compliance with quality management systems.
   • Answer: In my previous roles, I have been involved in preparing project reports, SOPs, and other documentation to ensure compliance with quality management systems. For instance, I developed a comprehensive project report detailing the development and validation of an analytical method, including all necessary parameters, protocols, and results. This report served as a reference for future projects and was well-received during internal audits.

Remember to tailor your answers based on your own experiences and achievements. Good luck with your interview!

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