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. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.
Post : Research Associate II
Position Summary:
The role involves support to bioanalytical activities required as per established SOPs and protocols. The incumbent must demonstrate proven record of hands on experience on instruments like HPLC, LCMS, ELISA, and MSD. He / She must also be able to demonstrate the skill of preparing biological samples by different techniques, including LLE, PPT, SPE, 96 well plate and micro titer plate sample preparation methods. Maintains up to date knowledge of bioanalytical guidelines and industry practices. Must have ability to develop robust bioanalytical methods. Must be able to review instrument and raw data. Executes the activities as per written procedures and in a timely manner and records all activities to ensure traceability. Updates Manager / Supervisor routinely on the outcome of results.
Responsibilities:
Bioanalytical methods and Analysis of study samples: Develop bioanalytical methods for New Chemical entities, drugs, metabolites in different biological matrices using LC-MS/MS. Perform Method validation and sample analysis.
Study Sample accountability: Responsible for accountability of study and stability samples
SOP and trainings: Understand SOPs and procedures.
Commitment to Quality: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
Documentation accountability of Study / Method Validation file: Checking of data accuracy and integrity, data collation and report preparation.
Interface with Quality Assurance: For data and reports accuracy, closure of observations and preparation of final report.
Calibration / maintenance of instrument: Ensure timely calibrations and maintenance of equipment under your accountability.
Routine procedures and systems checks: Review general documents, log-books, calibration records required in assuring GLP compliance and report findings to supervisor.
Document management: Ensure safe custody of study and method validation file and their archiving as per established procedure.
Responsibilities allotted by Supervisor.
Flexibility: Needs to be flexible in working hours to accommodate as per the project needs and with cross functional teams.
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Candidate Profile
A masters M.Sc /M.Pharm degree along with a minimum of 3-5 years of relevant skills in pharmaceutical/biotech industry is required.
Hands on experience to operate instruments like HPLC, UPLC, LCMS, ELISA, MSD to quantify drugs and their metabolites in biological matrices. Hands on with routine instruments like pH meters, weighing balances, centrifuges, shakers, single and multichannel pipettes and Milli Q system.
Ability to develop efficient and robust bioanalytical methods. Hands on experience with sample preparation of small and large molecules using techniques like LLE, SPE, PPT, 96 well plate, micro titer plate assays and automated liquid handling system. Knowledge of Good Laboratory Practices (GLP) procedures and bioanalysis related guidance documents on OECD and USFDA, EMA.
Ability to review experimental data, SOPs, procedures, reports. The hands on experience with electronic data management like LIMS will be considered an added advantage. Good understanding of Chromatography.
Familiarization with computer is essential (MS word, MS Excel, Power point).
Must be willing to work as part of a team and should have good Well versed with good interpersonal skills, presentation and communication skill.
Communication: Well versed with English language
Additional Information:
Job ID: IN3180-3450-R
Experience: 3-5
Industry Type: Pharma/Biotech/Clinical Research
Location: Hyderabad
Functional Area: Bio-Analytical
End Date: 30th March, 2018
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