• Job Description

  Req#: SCIEN003252

  At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise
  strengthens our ability to develop trusted public health standards. We foster an organizational culture
  that supports equitable access to mentorship, professional development, and leadership opportunities.
  Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific
  leadership results in stronger, more impactful outcomes for global health.

  
  USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring
  fair, merit-based selection processes that enable the best scientific minds—regardless of background—to
  contribute to advancing public health solutions worldwide. We provide reasonable accommodations to
  individuals with disabilities and uphold policies that create an inclusive and collaborative work
  environment

  Brief Job Overview
  
  This is a hands-on, non-supervisory position in USP-India’s Microbiology Lab, responsible for conducting lab
  test procedures as per USP’s Microbiology General chapters, Monographs and the incumbent in this role involves
  in Verification Programs, Method Verifications, Method Developments, Method Validations, Reference Standard
  Collaborative testing, Rapid Microbiology Methods and Training programs. The Scientist is also responsible for
  independent execution of project tasks when assigned in alignment to USP’s objectives and mission.

  How will YOU create impact here at USP?

  
  As part of our mission to advance scientific rigor and public health standards, you will play a vital role
  in increasing global access to high-quality medicines through public standards and related programs.
  USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure
  health systems worldwide can rely on strong, tested, and globally relevant quality standards.
  Additionally, USP’s People and Culture division, in partnership with the Equity Office, invests in
  leadership and workforce development to equip all employees with the skills to create high-performing,
  inclusive teams. This includes training in equitable management practices and tools to promote engaged,
  collaborative, and results-driven work environments

  The Scientist-IV/ Senior Scientist-I has the following responsibilities:

  
  • Hands-on Bench work (100 %): Carries out experimentation in the Microbiology area of Biologics lab and
  records experimental data, ensuring clear and accurate transcription of results and calculations.
  • Demonstrates strong skills and expertise in laboratory methods in microbiology. The tests include but not
  limited to Identification, Enumeration, pathogenic tests, Sterility test, Bacterial endotoxin test, Antibiotic
  assays.
  • Demonstrates strong communication skills in presenting laboratory driven data to internal stakeholders and
  independently delivers theory/hands-on webinar courses in microbiology as USP representative to Internal
  & External stakeholders.
  • Possess strong technical/ Hands-on experience in Disinfectant validation studies, Biological Indicators
  study & Microbial cultures-growth curve studies.
  • Support the manager in developing short term & long term new business solutions in Microbiology
  • Cross collaborate with global microbiology units, while integrating and impelementing lab based testing
  & performing R&D, POC & Lot release studies here in India site.
  • Independently Reviews, and evaluates test protocols and scientific literature and actively engages in the
  overall project and ensures own work is aligned with overarching goals
  • Independently executes all testing / analysis, and records experimental data, ensuring clear and accurate
  transcription of results and calculations
  • Reviews and sign the microbiology data such as and not limited to laboratory notebooks, microbiology
  projects, reports & supporting data.
  • Records experimental data, ensuring clear and accurate transcription of results and calculations and
  prepares reports.
  • Independently plans and executes experiments for project tasks assigned. Derives interpretation and
  conclusion of results.
  • Plans daily work, records and review results and documents to ensure correctness and to fulfill targets on
  time.
  • Completes assigned work with quality and in a timely manner. Assists the Manager in implementing
  laboratory procedures and systems. Coordinates and takes the lead with other team members as per
  requirement
  • Prepares protocols and reports including calculations and conclusions. Prepares presentations and
  documents related to projects and various scientific discussions as delegated.
  • Performs peer review of data as needed
  • Follows QMS practices. Recommends improvements to systems and all other supporting activities.
  • Assist the manager and takes the lead in planning, evaluating, and implementing lab procedures and
  systems. Takes part in audits as per delegation.
  • Follows and ensures aspects related to safety, ethics, and legal compliance

  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:

  Master’s degree in Microbiology (preferably)/Life Sciences with 11-13 (Senior Scientist-I) /8-10
  (Scientist-IV) years of experience in Microbiology quality control function working on Pathogen testing,
  Bioburden, Microbial Identifications, Disinfectant Validations & Environment Monitoring.
  • The other related tests include but not limited to ELISA Assays, Allergen testing, Antibiotic Potency assays,
  Sterility, Bacterial Endotoxin testing (Gel Clot, Kinetic), food and Water testing etc.
  • Documentation experience using automated softwares such as not limited to LIMS (Laboratory Information
  Management system), ELN (Electronic Laboratory Notebook).
  • Practical experience in execution of USP Compendial Microbiological test procedures and work experience
  of cGLP will be desired.
  • Experience in OOS, QMS, Deviations, SOP’s Management, handling Internal & External Audits.
  • Current MS office suite proficiency is must.

  Additional Desired Preferences

  Work/Sound Experience in Advanced/Rapid Micobiology Methods

  Performing Disinfectant Validations as per USP

  Testing of External PT (Proficiency Testing) for Pharma & Non Pharma projects

  The candidate must take personal responsibility to ensure work is delivered on time and is of the highest possible quality.

  • Basic understanding of scientific concepts, ability to anticipate, troubleshoots, solves technical problems and adaptive to multitasking.

  • Excellent communication skills, both verbal and written & presentation.

  • Should be able to use various Statistical models for Biological data calculations.

  • The ability to influence and work as an effective team member/ Team Leader.

  • Results driven with demonstrated successful outcomes

  Supervisory Responsibilities

  
  None, this is an individual contributor role.

  
  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 with USP

• About the company

  The United States Pharmacopeia is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.

Notice