Job Title: Assistant Manager – Analytical Development
Req ID: 1428
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 8,00,000 – 12,00,000 per annum
Job Type: Full-Time
Industry: Biopharmaceuticals / Biologics / Contract Development and Manufacturing (CDMO)
Experience Required: 4–8 Years
Education Required: MSc or M.Tech in Biochemistry / Biotechnology
Organisational Overview
Lambda Therapeutic Research Ltd. is a global Contract Development and Manufacturing Organization (CDMO) providing integrated solutions for biologics drug development, GMP manufacturing, and First-in-Human (FIH) clinical trials. The organization delivers scalable biologics development capabilities supported by advanced infrastructure, flexible manufacturing capacity, and a collaborative approach that accelerates product development from pilot batches to clinical production and market readiness.
Through its comprehensive service portfolio, the company provides end-to-end support for biologics, bio-therapeutics, and biosimilars development, ensuring regulatory compliance, quality assurance, and scientific precision across the development lifecycle.
Job Summary
The Assistant Manager – Analytical Development will support the development, validation, and implementation of physicochemical analytical methods for monoclonal antibodies (mAbs). The role involves delivering robust analytical methodologies, supporting process development activities, maintaining laboratory operations, and contributing to regulatory documentation for early-stage clinical development programs. The position requires strong technical expertise, regulatory knowledge, and cross-functional collaboration within a GLP and GMP environment.
Key Responsibilities
Provide technical expertise in physicochemical analytical methodologies for monoclonal antibodies.
Develop robust and regulatory-compliant analytical methods suitable for validation and routine application.
Execute analytical method transfer activities to Quality Control laboratories.
Provide in-process analytical support to process development teams.
Maintain analytical laboratory infrastructure and ensure comprehensive documentation of equipment performance and calibration.
Utilize and operate analytical platforms including NP-HPLC, RP-HPLC, SEC-HPLC, CEX, isoelectric focusing (cIEF), SoloVPE for protein concentration determination, CE-SDS (Sciex), and mass spectrometry.
Maintain working knowledge of electronic laboratory notebook (eLN) and Quality Management System (QMS) platforms.
Apply Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), and Circular Dichroism (CD) spectroscopy techniques where required.
Interpret regulatory guidance and USP chapters related to analytical method validation and GLP compliance.
Provide technical input for analytical method development, validation, and troubleshooting activities.
Support GMP investigations and resolve deviations in physicochemical analytical results.
Author and review technical reports and contribute to regulatory documentation supporting IND-enabling studies and early-phase clinical trials.
Required Technical Skills and Competencies
Strong expertise in physicochemical characterization of monoclonal antibodies.
Hands-on experience with chromatographic and electrophoretic analytical techniques.
Understanding of analytical method validation guidelines and regulatory requirements.
Experience working within GLP and GMP environments.
Strong problem-solving, analytical thinking, and troubleshooting capabilities.
Excellent technical writing and documentation skills.
Ability to work collaboratively with cross-functional teams in a regulated environment.
Experience Requirements
4–8 years of experience in developing and validating physicochemical methods for monoclonal antibodies within biopharmaceutical, biotechnology, or contract research organizations.
Preference will be given to candidates with prior experience in biopharma organizations specializing in physicochemical characterization of monoclonal antibodies.
Educational Qualifications
MSc or M.Tech in Biochemistry, Biotechnology, or related life sciences discipline.
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