Sr. Scientist (India)

Location
Hyderabad, India
Posted
Jul 12, 2018
Ref
2-1-IN3259-3450-2018
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

We are seeking a highly motivated senior scientist with hands-on experience in ELISA /ECL based PK/PD/ADA assay development. The individual will join the Global Bioanalytical Organization and play an active role in the development of Enzyme-Linked Immunosorbent Assay (ELISA) for early stage research, preclinical and later-stage development programs. He/she will have a strong background in immunoassay and other protein quantitation methods for PK/PD studies, with a deep understanding of the requirements needed for a robust assay. Ideally, he/she will have developed immunoassays for novel protein-polymer or other atypical protein analytes, 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. Experience in transferring methods to CROs for GLP assay development is highly desirable. The position may also require working with CROs to generate the necessary antibodies. 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.

Responsibilities:

Summary: Extensive hands on experience expertise in quantitative assay development in large molecules. Proven success in managing multiple projects and working with cross-functional teams.
Flair for trouble shooting and problem solving attitude. Excellent communications, interpersonal skills and organizational skills. Provide strategic oversight to bioanalysis of biologics in different biological matrices. Ability to develop Ligand binding assays in biological matrix from scratch.
Develop and qualify ELISA/ECL based PK/PD/ADA assays to support preclinical and clinical studies, drug safety evaluations. Develop protocol for sample preparation and analysis of assays. Familiarization with GLP and GCP guidelines, white papers and industry practices. Identify and develop appropriate immunoassays for new chemical entities and biomarkers on ELISA, MSD platform other methods to quantify proteins in complex matrices such as plasma or serum. Independently design and conduct experiments, and interpret and summarize data. Develop robust immunoassays or other assays to quantify challenging protein-polymer conjugates. Must be able to think creatively about assay development. Collaborate with members of the Protein Therapeutics team, other members of the Bioanalytical team, and interface in Research Biology and Pharmacology. Program and validate liquid handling systems for high throughput assay methods. Ensure assay robustness to allow successful inter lab transfer for GLP assay development. Work with CROs to generate necessary antibodies. Synthesize and interpret results - anticipate and understand caveats and 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 train / manage / supervise RAs and scientists to perform routine BA lab operation.
Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Good communication skills. Needs to communicate within organization and able to work in a team as well as independently.

Requirements:

Ph.D in Biochemistry, Protein Chemistry, Analytical Biochemistry, Chemistry, Analytical Chemistry or related area required. A minimum work experience in a research and/or development environment is required. 6-8 years for Ph.D and 10-12 years for exceptional Masters with demonstrated capabilities and/or significant experience may also be considered. Must be comfortable with standard protein chemistry and biochemical methods such as Bradford or BCA protein quantitation. Demonstrated expertise in a broad range of assay and 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. Demonstrated ability to develop quantitation assays for atypical protein analytes. Must be comfortable working with CROs and developing appropriate documentation for technology transfer. Demonstrated capabilities with a variety of robotic liquid handling systems, including programming and testing, in addition to producing results. Demonstrated computer and data analysis skills. Must be able to present and summarize data. Demonstrated intellectual leadership, creativity and strategic thinking within his/her area of expertise. Excellent oral and written communication skills. Hands on experience on LC-MS/MS and electronic data management like LIMS will be considered an added advantage. Knowledge of Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD, USFDA and EMA.