Associate Scientist

Job Description

We are seeking a highly motivated scientist 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 assays with a good understanding to develop a robust assay. Ideally, he/she will have developed immunoassays for novel protein-polymer, 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. Experience in transferring methods to CROs for GLP assay development is highly desirable. The ideal candidate will be able to work with robotic liquid handling systems, including programming and validating results from automated systems. The ideal candidate will be independent, have excellent interpersonal skills and will thrive in a goal-oriented, team environment. The ability to manage multiple teams and multiple tasks across different sites is a plus.ResponsibilitiesDevelop appropriate immunoassays for new chemical entities and biomarkers using ELISA and MSD platform to quantify proteins in complex matrices such as plasma or serum. Independently design and conduct experiments, and interpret and summarize data. Must be able to think creatively about 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.Regular interaction with QA (Quality Assurance) during data and reports review, closure of observations, reports sign off and archival.Ensure timely calibrations and maintenance of equipment.Collaborate with other members of the Bioanalytical team, and Research Biology and Pharmacology teams.Ensure assay robustness to allow successful inter lab transfer for GLP assay development Program and validate liquid handling systems for high throughput assay methods.Interpret results anticipate and understand the issues related to the assay.Participate in, and present data to project teams. Communicate with research management on a regular basis and assist with development of research goals and strategies.May need to manage and supervise junior scientists to perform routine BA lab operation.Requirements:A recent Ph D or M/.Sc or MPharm in Pharmacy, Biochemistry, Protein Chemistry, Analytical Biochemistry, Chemistry, Analytical Chemistry with 5-9 years work experience in a research and/or development environment is required.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 work with CROs for technology transfer.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.Hands on experience on LC-MS/MS and electronic data management like LIMS, eLN will be considered an added advantage,

Keyskills :
validationhplc sopdocumentation protocolselectronic data management ligand bindingdata management