Senior Scientist, Analytical R&D
Location: Bangalore
Work Model: Partially Remote
Employment Type: Full Time
Job Overview
The Senior Scientist, Analytical R&D is responsible for supporting biosimilar development programs through Critical Quality Attribute (CQA) assessments, analytical strategy development, scientific data interpretation, protocol authoring, and preparation of regulatory-ready reports. The role plays a key part in analytical similarity and comparability assessments while collaborating closely with Analytical Development, Process Development, and Regulatory Affairs teams.
Key Responsibilities
Analytical Strategy & CQA Assessment
Perform Critical Quality Attribute (CQA) assessments for biosimilar development programs.
Define analytical strategies based on product characteristics, risk assessments, and regulatory expectations.
Support biosimilarity and comparability studies through scientifically justified analytical approaches.
Apply CQA-based methodologies to assess product quality and comparability.
Scientific Documentation & Reporting
Author and review study protocols with:
Scientific rationale
Acceptance criteria
CQA-based strategies
Interpret analytical data and provide concise scientific conclusions.
Author and review study reports for analytical similarity and comparability assessments.
Prepare technical content for regulatory submissions and supporting documentation.
Ensure reports are scientifically accurate, regulatory compliant, and submission-ready.
Data Analysis & Interpretation
Review analytical data for accuracy, consistency, and alignment with study objectives.
Interpret complex multi-attribute datasets and provide scientifically justified conclusions.
Analyze trends and identify potential product quality risks.
Support investigations related to analytical deviations and unexpected results.
Cross-Functional Collaboration
Collaborate with:
Analytical Development Teams
Process Development Teams
Regulatory Affairs Teams
Quality Teams
Provide scientific expertise during project discussions and development activities.
Support decision-making related to product characterization and biosimilarity assessments.
Regulatory & Compliance Support
Contribute to preparation of:
Analytical Similarity (AS) Reports
Comparability Assessments
Regulatory Submission Documents
Ensure compliance with:
ICH Guidelines
Biosimilar Development Requirements
Regulatory Expectations
Support responses to regulatory queries when required.
Qualifications
Education
Master's Degree (MS) in:
Biochemistry
Analytical Chemistry
Biotechnology
Related Scientific Discipline
OR
PhD in:
Biochemistry
Analytical Chemistry
Biotechnology
Related Scientific Discipline
Experience
MS with 6–10+ years of relevant industry experience.
OR
PhD with 2–4+ years of relevant industry experience.
Experience (Minimum Required)
Experience in biosimilar analytical characterization.
Experience authoring scientific reports and technical documentation.
Strong understanding of:
Analytical Similarity Studies
Comparability Assessments
Biosimilarity Principles
ICH Comparability Guidelines
Forced Degradation Studies
Experience reviewing and interpreting analytical characterization data.
Strong scientific writing and communication skills.
Ability to independently evaluate analytical results and provide recommendations.
Preferred Technical Skills
Analytical Characterization Techniques
HPLC / UPLC
Chromatographic Analysis
CE-SDS
cIEF
LC-MS
Glycan Analysis
Analytical Ultracentrifugation (AUC)
Dynamic Light Scattering (DLS)
FTIR
Differential Scanning Calorimetry (DSC)
Circular Dichroism (CD)
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | 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 :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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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 :
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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 :
Swords |Republic of China :
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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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Renfrew | Mississauga | Richmond Hill | Australia | North York | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
Hà Nội | Hanoi |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) :
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Remote Korea |Republic of Korea :
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Bangkok |Israel :
Kfar Saba | Tel Aviv | Netanya | Yavne | Be'Er Sheva |Remote :
Switzerland | Melbourne | Remote - South America (Latin Americal) | Texas | Tulsa | Zaragoza | Lousiana | Bishop | Victoria | Hammond | Slovakia | Minnesota | Riga | Xzagreb | Remote - Africa | Faridabad | Green Way | Remote - Europe | Nairobi | Regulatory Labeling Manager (NA and LATAM Only) | Manipal | Remote - Middle East | McFarland | Blue Bell | Ireland | Thailand | Bountiful | Belgium | French | Leinster | Milwaukee | Medan | Perth | Springville | Castlebar | Lenexa | Hungary |Republic of Colombia :
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Riyadh | King Abdullah Economic City | Jeddah | Najran | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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