US Pharmacopeia

Scientist IV / Senior Scientist I,Microbiology

US Pharmacopeia  •  Hyderabad, IN (Onsite)  •  4 months ago
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Job Description

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 <1072>

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

US Pharmacopeia

About US Pharmacopeia

US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health.

We are committed to building public trust and confidence in drug therapies to enable people to live longer and healthier, and also work to building trust in dietary supplements and food ingredients. Currently, we are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected.

Our Volunteers

USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers, through our Council of Experts and Expert Committees and Panels, is crucial for maintaining our standards and preserving public trust.

Our Governing Bodies

The USP Convention helps guide our areas of impact – nearly 500 Member Organizations from around the world contribute valuable perspectives, experiences, and expertise from across healthcare and science. In addition to collaborating on critical healthcare and science matters, every five years, Convention Members adopt USP Resolutions and elect USP’s Board of Trustees and the Council of Experts who lead USP’s standards-setting Expert Committees.

Visit www.usp.org to learn more.

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Rockville, Maryland
Year Founded
1820
Website
usp.org
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