Job Description

Description


Brief Job Overview


This is a non-supervisory position in Reference Standard Laboratory responsible for performing the required tests as part of the project and maintaining the GLP environment in the Laboratory. The incumbent will utilize his or her technical expertise, knowledge of pharmaceutical analysis in collaborative testing, efficient and effective laboratory operations.


How will YOU create impact here at USP?


In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments


The Scientist-II has the following responsibilities:


• Executes all testing and analysis of data with excellence and essentially no errors.
• Supporting Verification, GPH, PQM, stability and other departmental teams in terms of testing whenever needed.
• Responsible for sample archival, sample tracking and chemical inventory tracking in the laboratory.
• Coordination with supervisor to ensure completion of the projects allotted to the team.
• Completing the project as per the timelines and troubleshoot the scientific aspects of the projects on need basis.
• Responsible for performing the calibration of the equipment as per the schedule.
• Responsible for preparing, executing, and completing IQ/OQ/PQ of new instruments.
• Ensuring that the chemicals and column etc. are available for the projects and forward the purchase requisitions.
• Taking up any additional responsibilities assigned by Supervisor from time to time.
• Ensure all lab safety and GLP practices are maintained in the lab and participate actively in the internal and external audits and certification.


Who is USP 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:


The candidate must have strong analytical chemistry knowledge with the ability to analyze, interpret and report effectively on data from a variety of analytical instrumental tests (e.g., HPLC, GC, Wet analytical techniques, spectroscopic techniques). Well-developed organizational and interpersonal skills. Able to establish and nurture relationships with individuals of varying backgrounds, cultures and learning styles.


• Master's degree in chemistry or Pharmacy.


Experience:


• 3 to 6 years with relevant laboratory experience.
• Proven track record of consistently delivering projects on time and with high quality for API's.
• Expert in chromatographic analysis, particularly in HPLC.
• Proficient in other related analytical instrumentation such as Water determination, Loss on drying, Residue on Ignition, Titrations, Spectroscopic analysis (UV, IR etc.,).
• Knowledge of pharmaceutical testing requirements and test protocols involving compendial methods for reference materials (USP compendia, ICH guidelines, FDA regulations etc.).
• Must possess effective communication skills, both written and verbal.
• Expert in Empower software with knowledge on Audit trails and Custom fields.
• Must possess good technical and analytical skills to independently resolve or troubleshoot issues.
• Should have a strong understanding of GLP regulations and exposure to external regulatory audits.


Additional Desired Preferences


• Knowledge in other related analytical instruments (GC, Thermal, Elemental analysis, Mass analyzers etc.), Electronic Laboratory Notebook, ERP, QR coding system will be an added advantage.
• Understanding monograph procedures and participating in compendial methods for reference materials (USP, FCC, NF, etc.).
• Prior experience in a high-volume pharmaceutical manufacturing QC laboratory or Analytical R&D, or a contract pharmaceutical analytical laboratory testing organization is a plus.
• Awareness of GLP regulations, QMS, ISO/IEC 17025 and exposure to external regulatory audits is desirable.
• Ability to embrace and lead change. Extremely adaptable.


Supervisory Responsibilities


None


Benefits


USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.


Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement