Job Title
Senior Scientist – Documentary Standards (Biologics)
Work Mode
Non-Supervisory | Office-Based | Non-Laboratory Role
Organization
United States Pharmacopeia (USP) (USP–Biologics Standards Division)
About USP
United States Pharmacopeia (USP) is a global scientific nonprofit organization that develops public standards for medicines, ensuring their identity, strength, quality, and purity. USP standards are used globally and are legally enforceable in the United States by the FDA, supporting regulatory systems in more than 140 countries.
For more information, visit: United States Pharmacopeia
Job Summary
We are seeking a Senior Scientist – Documentary Standards (Biologics) to serve as a key scientific liaison between industry, regulatory agencies, USP Expert Committees, and internal USP teams.
This is a non-laboratory, highly collaborative scientific role focused on developing and advancing USP documentary standards for biologic and advanced therapeutic products including monoclonal antibodies, therapeutic proteins, peptides, oligonucleotides, vaccines, antibiotics, and gene therapy products.
The role drives scientific consensus, supports standards development strategy, and facilitates global collaboration across stakeholders to advance public health standards.
Key Responsibilities
Standards Development & Scientific Leadership
Facilitate development of USP documentary standards for biologics and advanced therapies.
Identify opportunities for new standards addressing emerging analytical challenges.
Develop strategies to support continuous pipeline of biologics standards.
Provide scientific leadership to USP Expert Committees and Expert Panels.
Stakeholder Engagement & Collaboration
Serve as liaison between industry, academia, regulatory agencies, and USP departments.
Build and maintain relationships with global scientific and regulatory stakeholders.
Lead collaborative projects with academic and industry partners.
Facilitate exchange of complex scientific and regulatory information.
Scientific Evaluation & Strategy
Analyze internal and external data to identify standardization opportunities.
Evaluate scientific literature and technical reports to inform decision-making.
Define next steps and scientific strategies for standards development.
Stay updated on emerging trends in biologics, especially monoclonal antibodies and therapeutic proteins.
Cross-Functional Coordination
Work with internal USP departments including standards production and biologics program units.
Collaborate on development of application notes, training materials, and educational content.
Support handover of scientific work to standards production teams.
External Representation & Communication
Represent USP at scientific conferences and industry forums.
Deliver technical presentations on USP standards and initiatives.
Communicate complex scientific concepts to technical and non-technical audiences.
Expert Panels & Working Groups
Lead and manage expert panels and industry working groups.
Define project scope and coordinate stakeholder contributions.
Recruit and engage subject matter experts for collaborative projects.
Optional Laboratory & Feasibility Support
Oversee laboratory feasibility and proof-of-concept studies (as needed).
Coordinate with internal/external labs for round-robin and validation studies.
Required Qualifications
Education & Experience
PhD in Analytical Chemistry / Biochemistry / Biology / Related Field
7–10 years of relevant bioanalytical/biopharmaceutical experience
OR
Master’s Degree (MSc) in relevant field
11–13 years of industrial experience in biopharmaceutical development
Required Skills & Competencies
Scientific Expertise
Strong experience in biotherapeutics (mAbs, proteins, peptides, oligonucleotides).
Expertise in bioanalytical characterization and method development.
Strong understanding of CMC (Chemistry, Manufacturing & Controls).
Experience in method development, validation, transfer, and system suitability.
Regulatory Knowledge
Familiarity with global regulatory frameworks (FDA, WHO, ICH).
Understanding of regulatory filing approaches for biologics.
Knowledge of reference standards and pharmacopeial systems (USP-NF preferred).
Stakeholder & Communication Skills
Strong ability to engage with diverse stakeholders (industry, academia, regulators).
Excellent written and verbal communication skills.
Ability to translate complex science into clear recommendations.
Strong presentation and public speaking ability.
Project & Program Management
Ability to manage multiple long-term, complex scientific projects.
Strong prioritization and organizational skills.
Ability to work independently and escalate issues appropriately.
Experience managing cross-functional scientific initiatives.
Behavioral Competencies
Strong relationship-building and collaboration skills.
Ability to work in fast-paced, evolving scientific environments.
High level of scientific rigor and analytical thinking.
Ability to influence without direct authority.
Preferred Experience
Experience with USP-NF or pharmacopeial systems.
Knowledge of reference standards development.
Experience in immunogenicity testing.
Experience in protein/peptide/oligonucleotide analysis.
Working Environment
Office-based scientific leadership role (non-laboratory).
High interaction with global scientific and regulatory communities.
Fast-paced, collaborative, and stakeholder-driven environment.
Why Join USP
Shape global public health standards for next-generation biologics.
Collaborate with global experts in science, industry, and regulation.
Influence how biologic medicines are evaluated worldwide.
Work at the intersection of science, policy, and global health impact.
Contribute to trusted standards used across 140+ countries.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Renfrew | North York | Mississauga | Australia | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Nairobi | Blue Bell | Ireland | Texas | Slovakia | Zaragoza | Hungary | Lenexa | Remote - South America (Latin Americal) | Remote - Africa | Remote - Europe | Medan | Springville | Castlebar | Minnesota | Remote | Victoria | Riga | Melbourne | Remote - Middle East | Green Way | McFarland | Belgium | French | Remote, USA | Leinster | Xzagreb | Bishop | Switzerland | Bountiful | Regulatory Labeling Manager (NA and LATAM Only) | Faridabad | Tulsa | Thailand | Manipal | Lousiana | Hammond |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Jeddah | Riyadh | Najran | Rabigh | King Abdullah Economic City | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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