Role of Scientist IV at USP – Latest Pharma / Chemistry Job – APPLY BELOW
Role : Scientist IV, Compendial Development Laboratory
Location : Hyderabad, India
Job Category : Chemistry & Scientific Standards
Job Type : Full-Time
Education : Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences
Brief Job Overview :
- This is a non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations.
- The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab.
- This position is a component of USP’s core business, and the incumbent is expected to support monograph modernization initiatives.
How will YOU create impact here at USP?
- Engage in project planning, execution, method development and validation of projects according to set standards as USP general chapters, guidelines, SOPs and protocols.
- Apply technical and scientific expertise in analytical method development and validation of pharmaceuticals.
- Prepare and review the project plans, reports, laboratory notebook/ Laboratory management system (LMS) and compile project data as per requirement.
- Adhere to GLP and safety practices while working in the Lab.
- Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.
Who USP is Looking For?
The successfulcandidate 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:
- Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience.
- Possess a fine understanding of USP/NF monographs/general chapters/general notices.
- Exposure to GMP/GLP/QMS environment and documentation procedures and champions the data integrity.
- Should be capable of performing analytical method developments and method validations using modern techniques and protocols.
- Good analytical skills in handling method development and Validations for Drug substances and Drug products.
- Should have exposure to GMP/GLP environment and documentation procedures.
- Awareness of ISO/IEC 17025 is desirable.
Additional Desired Preferences for the Role of Scientist IV at USP :
- Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience or Ph.D. with at least 4-7 years of experience in relevant field.
- Exceptional breadth of pharmaceutical industry experience.
- Excellent technical writing and oral communication skills required.
- Must be able to communicate effectively with diplomacy and enthusiasm.
- Technical and analytical skills required including the ability to interpret technical information.
- Must have hands on experience in working with chemical methods and handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR, UV-Visible.
- Should have good understanding of GLP regulations and exposed to external regulatory audits.
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Here are some potential interview questions along with sample answers for the Role of Scientist IV at USP :
1. Can you describe your experience with analytical method development and validation for USP/NF monographs?
Sample Answer: Certainly. In my current role, I have been responsible for analytical method development and validation for USP/NF monographs. I have a solid understanding of USP general chapters, guidelines, and protocols, which I apply to ensure that our methods meet the required standards. I’ve successfully developed and validated methods using modern techniques and protocols, ensuring accurate and reliable results for drug substances and drug products. My experience in this area allows me to contribute effectively to monograph modernization initiatives.
2. How do you ensure compliance with GLP and safety practices while working in the laboratory?
Sample Answer: Ensuring compliance with GLP and safety practices is a top priority for me. I strictly adhere to established protocols and guidelines when conducting experiments or handling chemicals. I maintain accurate documentation in my laboratory notebook and our Laboratory Management System (LMS). I consistently follow proper safety protocols, such as wearing appropriate protective gear and disposing of hazardous waste correctly. By upholding these practices, I create a safe and compliant environment for myself and my colleagues.
3. Could you share an example of a challenging project you’ve worked on and how you approached it?
Sample Answer: Certainly. In a recent project, I was tasked with developing an analytical method for a complex drug formulation. The challenge was to achieve accurate and reproducible results due to the formulation’s unique characteristics. I started by conducting an in-depth literature review to identify suitable techniques. I collaborated closely with my team to design a comprehensive method that involved utilizing LC-MS and FTIR. Through iterative testing and optimization, I successfully developed a robust method that met the project’s goals and delivered consistent results.
4. How do you stay updated on the latest developments in the field of analytical chemistry and pharmaceutical sciences?
Sample Answer: Staying updated in my field is crucial to me. I regularly attend conferences, webinars, and workshops related to analytical chemistry and pharmaceutical sciences. I’m an active member of professional associations and online forums where experts share their insights. I also subscribe to reputable scientific journals and publications to keep up with the latest research and advancements. By staying well-informed, I ensure that I can apply the most current knowledge and techniques to my work.
5. Can you provide an example of a time when you had to communicate technical information effectively?
Sample Answer: Certainly. In a previous role, I was tasked with presenting the results of a method validation to a cross-functional team, including non-technical stakeholders. I recognized the importance of clear communication. I prepared a concise presentation that highlighted the significance of the validation, explained the technical aspects in a simplified manner, and showcased how it aligned with regulatory requirements. By tailoring my communication to the audience, I ensured that everyone understood the findings and the impact they had on the project.
ALL THE BEST !