I am recruiting for a Senior Process Development Scientist (specialisation Cell based bioassays) for a 12 month contract with potential for extension. This Scientist will be responsible for providing practical hands-on support in the areas of Relative Potency Cell Based Assays, Receptor Binding Assays, ELISA, and Enzyme Kinetics.
The successful candidate will have proven Bioassay, Binding Assay, ELISA practical experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have a strong understanding of customer service and collaborate with QC colleagues to effectively troubleshoot analytical issues.
The successful candidate will also have a strong understanding of laboratory automation, Data Integrity principles and compliance in the laboratory as well as good presentation/influencing skills (Influencing with Data/ Data storytelling). Proven experience with the use of statistical packages to aid analytical method troubleshooting, and experience with automated liquid handlers for assay execution would also be a distinct advantage.
- Hands-on practical experience within a GMP lab executing Cell Based Bioassays is a must
Key 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 timely completion of Laboratory Investigations, Deviations, Process monitoring assessments
- 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 4 - 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.
