Associate Scientist

• Customer complaint analysis for DP samples
• Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards
• Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment at ADL
• Act as support for the Attribute Sciences function on cross functional teams/programs
• Timely documentation of Analytical data in the electronic notebook system
• Participate in the peer review of analytical data
• 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 , PMAFs
• Participate in internal/external audits/inspections as required
• Manage and contribute to the achievements of department productivity and goals
• Engage with the Continuous Improvement Process and MyGreenLab® philosophy
• Supporting activities related to customer complaint analysis
• Forensics & Defects activities involving forensic identification of Drug Product defects and also maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products

• Hold, at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline
• Have 3-6 years of experience in the Pharmaceutical Industry
• Forensic analysis skills including use of Optical Stereomicroscopes
• Excellent written and verbal communication skills
• 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
• Experience with developing, validating, troubleshooting, analytical methods
• Understanding of the Change Control and Variation Management Process
• Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating
• Understanding of data flow in laboratory systems and data integrity
• Proven experience acquired in the Pharmaceutical Industry
• Right first-time mindset
• Team player
• Excellent communication skills
• Focussed on delivering on our customer needs
• Strong understanding of Data Integrity principles, Quality and Compliance in the laboratory
• Good presentation/influencing skills

Experience with Regulatory inspections and interaction with inspectors is preferable