Biotech Commercial Attribute Scientist - Dun Laoghaire, Dublin Office/Project Location: Dun Laoghaire, Dublin Employment Type: Contract Work Location: Site based Pay: €30 - €36 per hour Experience: 3 + years Visa: EU passport or Stamp 4 visa required Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
This is an on-site Laboratory based role with responsibility for Analytical Support activities involving: Analytical Method Troubleshooting, Analytical Method Lifecycle (Development, Qualification, Validation, Remediation) Analytical support for Process Development and Qualification activities at the site and wider network.
The successful candidate will have proven analytical experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs.
This isn't a role where you have x number of samples to test per week and routine execution to the method.
This role is more troubleshooting service focused.
So there's always issues and there's always challenges.
You will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.
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 maximise operating efficiency.
Manage and contribute to the achievements of department productivity and goals.
Engage with the Continuous Improvement Process and MyGreenLab® philosophy.
Requirements Third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
3-6 years of relevant analytical experience in the Pharmaceutical Industry HPLC Experience is a must.
Interview will focus on technical questions on HPLC.
Empower CDS at a power-user/advanced user level.
Demonstrate Troubleshooting Abilities that would gall under the design of experiment, troubleshooting, hypothesis testing, etc.
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.
Package Contract role - Hourly rate €35 - €42 per hour Minimum 12 month contract with the possibility of an extension.
This is a lab-based running instrumentation role therefore there is a need for the candidate to be onsite FIVE DAYS per week.
The core hours are 08:30 to 17:0-00, Mon – Fri.