Job Title: Assistant Manager – Analytical Development
Req ID: 1427
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: PhD in Biochemistry/Biotechnology or MSc in Biochemistry/Biotechnology
Organisational Overview
Lambda Therapeutic Research Ltd. operates as a leading Contract Development and Manufacturing Organization (CDMO), delivering integrated solutions for biologics drug development, GMP manufacturing, and First-in-Human (FIH) clinical trials globally. The organization provides scalable manufacturing capabilities, advanced equipment infrastructure, and a collaborative development approach to accelerate biologics from pilot batches to clinical production and market readiness.
The company offers end-to-end support across biologics and biosimilar development pathways, ensuring high standards of quality, precision, and regulatory compliance through advanced technical expertise and innovative scientific methodologies.
Job Summary
The Assistant Manager – Analytical Development will be responsible for developing, validating, and transferring physicochemical analytical methods for monoclonal antibodies (mAbs). The role involves delivering robust analytical solutions, supporting product characterization, and ensuring compliance with global regulatory standards. The position requires collaboration with cross-functional teams, technical oversight of analytical operations, and contribution to regulatory documentation supporting clinical development programs.
Key Responsibilities
Provide technical expertise in physicochemical analytical methodologies for monoclonal antibodies.
Develop and deliver robust analytical methods suitable for validation and regulatory submission.
Manage analytical method transfer to Quality Control laboratories.
Collaborate with process development teams to evaluate product quality using qualified analytical techniques.
Maintain analytical laboratory operations and ensure accurate documentation of equipment performance.
Utilize and troubleshoot analytical software and systems related to NP-HPLC, peptide mapping, RP-HPLC, SEC-HPLC, CEX, cIEF, SoloVPE, CE-SDS (Sciex), and mass spectrometry.
Operate and troubleshoot analytical instruments including Capillary Electrophoresis systems, HPLC, UPLC, Empower, eLN, and QMS platforms.
Apply Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), and Circular Dichroism (CD) spectroscopy techniques where applicable.
Implement statistical tools to assess analytical method performance, robustness, and reliability.
Conduct analytical similarity studies in accordance with regulatory guidelines from RCGM, DCGI, EMA, MHRA, FDA, ICH, WHO, and USP.
Provide technical support for method development, validation, and troubleshooting activities.
Participate in GMP investigations and address deviations in physicochemical analytical outcomes.
Author and review technical reports and contribute to regulatory submissions supporting IND-enabling studies and early clinical trials.
Identify and promote best practices within CDMO analytical development functions.
Required Technical Skills and Competencies
Strong expertise in physicochemical method development and validation for monoclonal antibodies.
In-depth knowledge of chromatographic and electrophoretic analytical techniques.
Experience working within GLP and GMP environments.
Understanding of global regulatory requirements for analytical method qualification and validation.
Strong analytical thinking, problem-solving, and troubleshooting capabilities.
Excellent technical documentation and communication skills.
Ability to work effectively in cross-functional and collaborative environments.
Experience Requirements
4–8 years of experience in physicochemical method development and validation for monoclonal antibodies within biopharmaceutical, biotechnology, or contract research organizations.
Educational Qualifications
PhD in Biochemistry or Biotechnology, or
MSc in Biochemistry or Biotechnology.
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