Research Executive

Lambda Therapeutic Research Limited; India; On-site; INR 400,000 - 800,000; Full time

Job summary

Lambda Therapeutic Research Limited in India seeks a MV report writer to prepare method validation reports for PK/PD and immunogenicity assessments, following GLP and non-GLP guidelines.

You will coordinate with operations, QA and QA teams to finalize reports, maintain SOPs, and ensure timely delivery, with 2+ years of MV report writing experience in small molecules or biologics.

Qualifications

• 02 or more years of MV report writing experience in small molecules/biologics per regulatory guidelines.
• MSc in Biotechnology/Biochemistry/Life Science.
• Experience with GLP and non GLP regulatory guidelines.

Responsibilities

• Prepare MV reports for pk/pd/immunogenicity assays.
• Coordinate with operations to compile data for MV reports.
• Coordinate with QA/QC for review and resolve queries.
• Ensure proper formatting and finalization of MV reports.
• Maintain track of method validation and meet timelines.
• Prepare/update/maintain SOPs related to MV report preparation.

Skills

MV report writing

Regulatory guidelines

GLP compliance

Education

MSc in Biotechnology

MSc in Biochemistry

MSc in Life Science

Job description

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Company: Lambda Therapeutic Research Ltd.

CTC Range (INR): 400000 - 800000

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquartersin Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA),Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-endclinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Act as a MV report writer for preparation of method validation report for small molecules and LBA based PK, PD and Immunogenicity assessment as per GLP & non GLP regulatory guidelines

KEY DELIVERABLES

Prepare Method validation Reports for pk/pd/Immunogenicity Assays as per required GLP & non GLP regulatory guidelines

Coordinate with operation team and compile relevant data required for preparation of MV Report

Coordinate with Quality control and Quality Assurance team for QC & QA review of MV Report and resolve QC & QA queries.

Ensure proper formatting and finalization of MV Report

Maintain track of method validation and manage MV report preparation to meet the timelines.

Prepare/update/maintain SOPs related to MV Report preparation.

EXPERIENCE

02 or more years of MV Report writing experience in small molecules/ Biologics/ Biosimilar as per regulartory guidelines

EDUCATIONAL QUALIFICATION

MSc in Biotechnology/Biochemistry/Life Science