Research Executive
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, Gujarat
Req ID: 1584
Employment Type: Full-Time
CTC Offered: ₹4 – ₹8 LPA
About the Role
Lambda Therapeutic Research is seeking a Research Executive with experience in Method Validation (MV) Report Writing for Bioanalytical studies. The role involves preparation, review, coordination, and finalization of Method Validation Reports for PK, PD, and Immunogenicity assays in compliance with GLP and non-GLP regulatory guidelines.
Key Responsibilities
Method Validation Report Writing
Prepare Method Validation (MV) Reports for:
Pharmacokinetic (PK) Assays
Pharmacodynamic (PD) Assays
Immunogenicity Assays
Develop reports for:
Small Molecules
Biologics
Biosimilars
Ensure compliance with GLP and non-GLP regulatory requirements.
Data Compilation & Documentation
Coordinate with operational teams to collect and compile required study data.
Review analytical and validation data before report preparation.
Ensure completeness, accuracy, and consistency of report content.
Quality Review Coordination
Coordinate with:
Quality Control (QC)
Quality Assurance (QA)
Address QC and QA review comments.
Resolve report-related observations and queries within timelines.
Report Finalization
Ensure proper formatting and regulatory compliance of reports.
Finalize and submit reports as per project timelines.
Maintain document version control and audit readiness.
SOP & Compliance Management
Prepare, review, and update SOPs related to Method Validation Report Writing.
Ensure adherence to internal procedures and regulatory guidelines.
Support continuous process improvement initiatives.
Project Tracking & Timeline Management
Maintain tracker for ongoing Method Validation activities.
Monitor report preparation timelines and deliverables.
Coordinate with stakeholders to ensure timely completion of reports.
Required Qualifications
Education:
M.Sc. Biotechnology
M.Sc. Biochemistry
M.Sc. Life Sciences
Required Experience
Minimum 2+ years of experience in Method Validation Report Writing.
Experience with:
Small Molecules
Biologics
Biosimilars
Experience working according to regulatory guidelines and bioanalytical standards.
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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Remote, India | Siliguri |Illinois :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
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China | Quarry Bay |Liaoning :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Manila |Croatia :
Croatia |Zagreb :
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Tallinn |Hà Nội :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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South Africa | Midrand |Nišava District :
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Prague |Chile :
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