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 are easily validatable.
• Responsible for analytical method transfer to Quality Control Lab.
• Responsible for in-process support for process team.
• 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, RP-HPLC, SEC-HPLC, CEX, isoelectric focusing (cIEF), SoloVPE (for protein concentration determination), CE-SDS(Sciex) and mass spectrometry.
• Should have working knowledge of eLN and QMS
• A working understanding of Dynamic Light Scattering and Differential Scanning Calorimetry/CD spectroscopy methodologies will be preferable.
• Well versed with guidance documents for analytical method validation from various regulatory agencies, 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

EXPERIENCE

4 to 8 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 biopharma organizations that focus on physicochemical characterization of mAbs.

EDUCATIONAL QUALIFICATION

MSc/M.Tech. in Biochemistry/Biotechnology