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 complex matrices such as plasma, serum and urine. Independently design and conduct experiments. Must be able to think creatively about 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 QA (Quality Assurance) during data and reports review, closure of observations, reports sign off and archival.
• Ensure timely calibrations and maintenance of equipment.
• Review general documents, logbooks, calibration records required m assuring GLP compliance and report findings to supervisor.
• Ensure safe custody of study and method validation file and their archiving as per established procedure.
• Needs to communicate within organization and able to work in a team as well as independently
• Other duties, as assigned.
Candidate Profile :
• MSc/M.Pharm in Pharmacy, Biochemistry, Protem Chemistry, Analytical Biochemistiy, Chemistry, Analytical Chemistry or related area required with 6 to 8 years of relevant work experience in a research and or development environment is required.
• Expertise in a broad range of immunoassay techniques, mcludmg 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 : 6-8 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
Requisition Number : IN5470-3450-R
End Date : 30th November, 2021
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