Job Summary
This is a 12-month initial contract role with responsibility for Analytical Support activities involving analytical method troubleshooting, development, qualification, validation, and remediation.
Key Responsibilities
* Analytical method troubleshooting, qualification, validation, bridging, transfer
* Analytical support for Process Development and Process Qualification activities
* Act as support for the Attribute Sciences function on cross-functional teams/programs
* 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
* 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
* Plan and implement procedures and systems to maximize operating efficiency
* Manage and contribute to the achievements of department productivity and goals
* Engage with the Continuous Improvement Process and MyGreenLab philosophy
Qualifications
* Hold, at a minimum a third-level qualification (Degree) in Analytical Chemistry/Biochemistry or related discipline
* Have 3-6 years of relevant analytical experience in the Pharmaceutical Industry
Knowledge and Experience
* Subject Matter Expert for General and Compendial methods used in the analysis of Drug Product such as Sub Visible Particle Analysis, KF Moisture, Ph, Osmolality, Density, App/Colour/Clarity, CCI, Breakloose and Extrusion, RAMAN, FTIR, NIR, UV/VIS Spectrophotometry, SEM
* Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favourable but not essential
* Excellent written and verbal communication skills Science based decision maker
* 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 Process Validation activities (Engineering, PPQ, Comparability/Characterisation studies)
* 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