Deputy 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

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.