Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates.
Post : Sr. Research Associate
Job Description
• Develop appropriate immunoassays for New Biological Entities (NBEs) and Biomarkers using ELISA and MSD platforms to quantify analytes m 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 bioanalvtical guidance/ industry practices/intemal SOPs.
• Ensure activities conducted in the bioanalvtical 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
Candidate Profile
• 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
Additional Information
Experience : 5 to 7 years
Qualification : MSc/M.Pharm
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
Requisition Number : IN5337-3450-R
End Date : 10th May, 2021
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