Commercial Attribute Science Snr Associate (Lab Based)

Team Horizon is seeking a  Commercial Attribute Science Snr Associate (Lab Based) for our client based Dublin.in The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture 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.


• 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.

What you need to apply:

• 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 


• 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.