Deputy Manager - Analytical Development

Lambda Therapeutic Research Ltd.; India; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Lambda Therapeutic Research Ltd. invites a Deputy Manager - Analytical Development to lead physicochemical method development for monoclonal antibodies using CHO or murine systems, with a focus on qualification and validation for batch release.

The role demands PhD/ MSc with extensive hands-on experience in HPLC/UPLC, MS, CE, and related analytical technologies, along with team leadership and regulatory awareness across ICH, WHO, and FDA references.

Qualifications

• PhD in Biochemistry/Biotechnology with 4-8 years or MSc in Biochemistry/Biotechnology with 8-12 years developing and validating physicochemical methods for mAbs.
• Experience leading a team in biopharma/biotech or CROs focusing on physicochemical characterization of mAbs.
• Strong understanding of analytical techniques including HPLC/UPLC, MS, CE, DLS, DSC, CD spectroscopy.
• Familiarity with regulatory expectations (ICH, WHO, FDA) and GLP environment.
• Experience with regulatory submissions and IND enabling data is a plus.

Responsibilities

• Develop and validate physicochemical analytical methods for monoclonal antibodies.
• Lead a team to develop, qualify and transfer methods to QC labs.
• Provide technical inputs for method development, troubleshooting and documentation.
• Author and review technical reports and portions of regulatory submissions.
• Collaborate with process teams to assess product quality using analytical methods.
• Maintain analytical labs and equipment documentation.

Skills

Analytical method development

Team leadership

HPLC/UPLC

Mass spectrometry

Capillary electrophoresis

Data analysis

Regulatory awareness

Education

PhD in Biochemistry/Biotechnology

MSc in Biochemistry/Biotechnology

Tools

NP-HPLC

Peptide mapping

RP-HPLC

CEX

Maurice capillary electrophoresis

SEC-HPLC

DLS

DSC

CD spectroscopy

Mass spectrometry

Capillary electrophoresis

HPLC/UPLC

Empower/eLN/QMS

Job description

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Job Title: Deputy Manager - Analytical Development

Date: Jul 14, 2026

Location: Ahmedabad, India

Company: Lambda Therapeutic Research Ltd.

CTC Range (INR): 1000000 - 1500000

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development,GMP manufacturing , and to enable First in Human (FIH) clinical trials globally.

Our flexible capacity and equipment trains, combined with our agile, collaborative approach, give us the ability to scale up any biologic product for each unit operation – from pilot batch to clinical quantities – to accelerate the time to file and market.

In this integrated offering, the following cutting-edge technical functions will be fully engaged in providing end-to-end support to our customers in bolstering the development pathway for their lead biologics/bio-therapeutics or biosimilars, ensuring quality, precision, and success.

JOB DETAILS

The candidate should develop physicochemical analytical methods within the Analytical Sciences group. The role entails utilization of the prospective candidate’s vast technical experience to lead a team that will be focused on development, qualification and validation of physicochemical methods for batch release for monoclonal antibodies (mAbs) using CHO or murine myeloma cell lines as expressions systems. The candidate should have experience in characterization of structural attributes using additional techniques including Mass Spectrometry (Optional) and tools for assessing higher order structure of bio-therapeutics.

KEY DELIVERABLES

• Provide technical inputs for physicochemical analytical methodologies for monoclonal antibodies (mAbs).
• Responsible for delivering robust analytical methods that can be easily validated.
• Responsible for analytical method transfer to Quality control lab.
• Must actively work with the process teams to evaluate product quality using qualified physicochemical methods for mAb characterisation.
• Responsible for maintenance of the analytical labs including thorough documentation on the performance of all analytical equipment.
• Should have strong understanding of software’s used in NP-HPLC, Peptide mapping, RP-HPLC, SEC-HPLC, CEX, isoelectric focusing (cIEF), SoloVPE (for protein concentration determination), CE-SDS(Sciex) and mass spectrometry.
• Should have working knowledge and troubleshooting of Capillary electrophoresis systems, HPLC, UPLC and Empower,eLN and QMS
• A working understanding of Dynamic Light Scattering and Differential Scanning Calorimetry/CD spectroscopy methodologies will be preferable.
• Must be focused on usage of statistical tools to evaluate analytical method performance and robustness.
• Very well versed with analytical similarity studies as per RCGM, DCGI, EMA, MHRA and FDA requirements.
• Well versed with guidance documents for method qualification, method validation from various regulatory agencies, ICH, WHO and USP chapters as well as awareness to requirements of working in GLP environment.
• Providing appropriate technical inputs for analytical method development and validation, troubleshooting as and when required.
• Support in GMP investigations to address deviations in physicochemical method outcomes will be required.
• Responsible for authoring and reviewing technical reports, and portions of regulatory submissions to support IND enabling data to initiate early development clinical trials.
• Identify and communicate best practices within the CDMO function.
• Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development.
• Responsible for procurement of analytical consumables required for methods based on HPLC/UPLC/Maurice/ Sciex (CE)/ Solo-VPE etc.

Core Competencies

Building Effective Teams

• Empowers team members and encourages them to contribute their skills/ideas.
• Gets the right talent mix for the task. Shares credit and celebrates wins.

Process Management

• Strong organizational skills, including the ability to prioritize personal and direct report’s workload.
• Abreast with the latest technical innovations and familiarity with Regulatory expectations
• Able to analyze analytical data and provide inputs for process optimization.
• Resourceful, uses resources and people wisely.
• Very good understanding and implementation of the good documentation practices including paper and electronic record keeping.
• Sufficient industry experience in handling cross functional interactions.
• Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups.

ALLIED RESPONSIBILITIES

• Minimum two years of experience in Biosimilar for physico-chemical method development and validation are highly desirable. This includes vast experience in different analytical tools including, SEC-HPLC, Peptide mapping, RP-HPLC, CEX, Maurice (capillary electrophoresis), NP-HPLC for glycan characterization in mAbs, DLS, DSC, CD spectroscopy, SEC-MALS and spectrophotometry-based methods.
• Significant experience in assessment of product purity, Impurity and identity for different mAbs, bi-specifics, receptor fusions and antibody fragments will be valued.
• Having experience of statistical software like GraphPad, JAMP, etc.
• Technical competence in appropriate scientific discipline or technology will be of great value.
• A strong working understanding of monoclonal antibodies
• Strong Cross functional communication skills is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.

EXPERIENCE

• PhD in Biochemistry/Biotechnology with 4-8 years or MSc in Biochemistry/Biotechnology with 8 to 12 years of work experience developing and validating physicochemical methods for mAbs in biopharma/biotech or relevant contract research labs.
• Preference will be for personnel having prior experience in leading a team in biopharma organizations that focus on physicochemical characterization of mAbs.

EDUCATIONAL QUALIFICATION

• PhD in Biochemistry/Biotechnology or MSc in Biochemistry/Biotechnology