Job Title
Senior Scientist I – Global Biologics (Analytical R&D & Reference Standards)
Work Mode
Onsite / Laboratory-Based
Organization
United States Pharmacopeia (USP) (USP–Global Biologics)
About USP
United States Pharmacopeia (USP) is a global scientific nonprofit organization that develops trusted public standards for medicines, food ingredients, and dietary supplements. These standards support regulatory compliance and are used in more than 140 countries. USP plays a critical role in improving global health by ensuring the quality, safety, and purity of healthcare products.
For more information, visit: United States Pharmacopeia
Job Summary
We are seeking a highly experienced Senior Scientist I to support biologics analytical research, reference standard development, and characterization programs.
This is a hands-on, individual contributor role focused on analytical characterization of biological molecules such as proteins, monoclonal antibodies, peptides, vaccines, enzymes, and other biologics.
The role involves executing complex analytical studies, supporting reference standard development programs, and contributing to compendial and R&D initiatives within a regulated scientific environment.
Key Responsibilities
Biologics Analytical Characterization
Perform advanced analytical characterization of biologics including:
Intact mass analysis
Peptide mapping
Glycan profiling
Impurity profiling (HMW/LMW)
Host cell protein (HCP) analysis
Post-translational modification (PTM) analysis
Execute qualitative and quantitative mass spectrometry studies.
Advanced Analytical Techniques
Operate and troubleshoot advanced instrumentation including:
HPLC / UPLC / Ion Chromatography
Capillary Electrophoresis
SEC-MALS
Circular Dichroism (CD)
Mass Spectrometry systems
Project Execution & Research
Plan and execute compendial and R&D projects in biologics.
Conduct proof-of-concept studies for biologic product classes.
Support characterization of proteins, peptides, monoclonal antibodies, vaccines, enzymes, antibiotics, and CGT products.
Identify and resolve technical challenges during experimental execution.
Reference Standards & Collaboration
Contribute to development and verification of biological reference standards.
Participate in international and national collaborative testing programs.
Coordinate with global cross-functional teams for biologics projects.
Quality Systems & Documentation
Prepare and review scientific reports, SOPs, and technical documentation.
Ensure compliance with USP Quality Management System.
Support internal audits, ISO 9001, and ISO 17025 compliance activities.
Maintain cGLP/cGMP-compliant documentation practices.
Scientific Analysis & Troubleshooting
Evaluate analytical data and troubleshoot experimental challenges.
Apply scientific reasoning and technical expertise to solve laboratory problems.
Ensure accuracy, reproducibility, and compliance of all experimental outputs.
Training & Mentorship
Provide guidance and training to junior team members.
Support knowledge sharing within the laboratory team.
Cross-Functional Collaboration
Engage with global scientific teams and stakeholders.
Support alignment with Global Biologics strategic objectives.
Collaborate with internal departments on project execution and reporting.
Required Qualifications
Education & Experience
PhD in Biochemistry / Analytical Chemistry / Biological Sciences
7–10 years of relevant experience (Senior Scientist I)
OR
MSc / M.Tech / M.Pharm in Biological Sciences
11–13 years of relevant experience in analytical R&D or QC (Biopharma industry)
Required Skills & Competencies
Technical Expertise
Strong hands-on experience with biologics (mAbs, peptides, vaccines, CGT products).
Expertise in analytical characterization of biomolecules.
Experience in method development, validation, and technology transfer.
Strong knowledge of analytical instrumentation and troubleshooting.
Regulatory & Quality Systems
Experience working in cGLP / cGMP environments.
Knowledge of QMS systems and good documentation practices.
Familiarity with USP reference standards development processes (preferred).
Scientific & Analytical Skills
Strong data interpretation and problem-solving abilities.
Ability to design and execute complex scientific experiments.
Strong technical reasoning and troubleshooting skills.
Communication & Collaboration
Excellent written and verbal communication skills.
Strong scientific writing and reporting ability.
Ability to collaborate with global cross-functional teams.
Strong presentation and stakeholder communication skills.
Behavioral Competencies
Strong ownership and accountability for scientific outcomes.
Ability to work independently in a research-driven environment.
High attention to detail and quality focus.
Strong adaptability in fast-paced scientific projects.
Preferred Experience
Experience in biopharmaceutical industry (R&D or QC).
Experience in reference standards or regulatory biologics programs.
Strong understanding of instrument operation and troubleshooting.
Working Environment
Laboratory-based scientific role with exposure to advanced biologics testing.
Highly regulated environment (cGLP/cGMP/ISO compliant).
Global collaboration with scientific and regulatory teams.
Why Join USP
Contribute to global public health through biologics standards development.
Work on advanced analytical technologies for cutting-edge biologic medicines.
Participate in international reference standards programs.
Be part of a mission-driven scientific organization impacting healthcare worldwide.
Collaborate with global experts in biologics and analytical science.
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
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Wuhan |Capital of Netherland :
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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Montreal |Brussels :
Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
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Ho Chi Minh City |Italy :
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New Mexico | Ciudad de México |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Niš |Bohemia :
Prague |Chile :
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