Job Title:  Assistant Manager - Analytical Development

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

• 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
• 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.
• Well versed with analytical similarity studies as per RCGM, DCGI, EMA, MHRA and FDA requirements and 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

EXPERIENCE

4-8 years work experience in developing and validating physicochemical methods for mAbs in biopharma/biotech or relevant contract research labs.

EDUCATIONAL QUALIFICATION

PhD in Biochemistry/Biotechnology or MSc in Biochemistry/Biotechnology