We are seeking a highly motivated Sr. Research Associate with hands-on experience in Ligand Binding Assay (LBA) development. The individual will join the Global Bioanalytical Organization and play an active role in the development of LBA assays for early stage research, preclinical and later-stage development programs. He/she will have a strong background in immunoassay and bioanalytical PK assay development. Ideally, he/she will have developed immunoassays for novel protein-polymers, where completely new methodologies may be needed. The successful candidate will develop, design and conduct studies in immunoassay or other assay-based protein quantitation from plasma, serum, or other complex matrices. The ideal candidate will be able to work with robotic liquid handling systems, including programming and validating results from automated systems.
- Develop appropriate immunoassays for New Biological Entities (NBEs) and Biomarkers using ELISA and MSD platforms to quantify analytes in complex matrices such as plasma, serum and urine. Independently design and conduct experiments. Must have a creative approach to assay development.
- Perform Method validation and sample analysis as per regulatory bioanalytical guidance/ industry practices/internal SOPs.
- Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
- Ensure assay robustness to allow successful inter lab transfer for GLP assay development program and validate liquid handling systems for high throughput assay methods.
- Regular interaction with Quality Assurance during data and reports review, closure of observations, reports sign off and archive
- Ensure timely calibration and maintenance of equipment
- Review general documents, logbooks, and calibration records required in assuring GLP compliance and provide updates to management
- Ensure safe custody of study and method validation files and their archiving as per established procedure
- Other duties, as assigned
- MSc/M.Pharm in Pharmacy, Biochemistry, Protein Chemistry, Analytical Biochemistry, Chemistry, Analytical Chemistry or related area required with 5 to 7 years of relevant work experience in a research and/or development environment.
- Expertise in a broad range of immunoassay techniques, including excellent liquid handling skills, both manual and robotic. Must be detail-oriented and able to conduct experiments in a precise and accurate manner.
- Expertise in bioanalytical method development using LBA techniques, excellent technical and problem-solving capabilities.
- Must have good knowledge on Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD, USFDA and EMA.
- Ability to summarize and present the data.
- Able to think creatively and strategically within his/her area of expertise.
- Possesses excellent oral and written communication skills.
- Ability to work as part of a team and independently
- Hands on experience on electronic data management like LIMS, eLN will be considered an added advantage