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Process development scientist

Recruitment by Aphex
Development scientist
Posted: 26 February
Offer description

PurposeCommercial Attribute Sciences -Analytical - Process Development ScientistThis Scientist role will be responsible for providing practical hands-on support in the areas of Relative Potency Cell Based Assays, Receptor Binding Assays, ELISA, Enzyme Kinetics.The successful candidate will have proven Bioassay, Binding Assay, ELISA practical experience acquired in the Pharmaceutical Industry.Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the role.Responsibilities:* Cell Based Assays, Receptor Binding Assays, ELISA, Enzyme Kinetics method troubleshooting, remediation and optimisation.* Use and troubleshooting of Liquid Handling Robotics for assay execution* Experience with statistical software packages for Analysis of Relative Potency Assay Data* Timely documentation of Analytical data in the electronic notebook system.* Understanding of data flow in laboratory systems and data integrity.* Participate in the peer review of analytical data.* Responsible for providing technical guidance and applying expertise and critical thinking to help resolve technical issues with Bio-analytical methods in QC.* Qualification of analytical equipment and related testing functions.* Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.* Ensure the laboratory is operated in a safe and environmentally friendly manner.* Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.* Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.* Ensure timely completion of Laboratory Investigations, Deviations, Process monitoring assesments* Participate in internal/external audits/inspections as required.* Plan and implement procedures and systems to maximise operating efficiency.* Manage and contribute to the achievements of department productivity and goals.* Engage with the Continuous Improvement Process and MyGreenLab philosophy.Knowledge and Experience:* Excellent written and verbal communication skills* Proven practical experience of execution Relative Potency Cell based Bioassay in a high throughput laboratory setting.* Practical experience of executing Relative Potency Binding Assay and ELISA in addition to Cell Based Assays would be a distinct advantage* Knowledge of liquid handling robotics - hardware use and maintenance practices* Experience with Regulatory inspections and interaction with inspectors is preferable.* Experience working with teams and influencing decisions.* Skilled in the use of problem-solving tools/techniques and proactively leading troubleshooting activities with drive and enthusiasm.* Experience with developing, validating, troubleshooting, bridging Bio-Analytical methods.* Understanding of the Change Control and Variation Management Process* Understanding how the use of statistical tools, such as multivariate analysis can aid method troubleshooting.Qualifications:* Hold a third level qualification (Degree) in Biology / Biochemistry / Biomedical science or related discipline.* Have ?6 years of hands-on experience in a pharmaceutical Laboratory executing Cell Based Relative Potency methods (in a PD and/or QC laboratory)* Strong background in Binding Assay, ELISA and Enzyme Kinetics based assays is preferred but not essential.* Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

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