Commercial Attribute Science Senior Associate
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Commercial Attribute Science Snr Associate
HPLC experience for this role is essentially required. Candidates will need to demonstrate troubleshooting abilities that would fall under the design of experiment, troubleshooting, hypothesis testing.
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 maximise 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.
* 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.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on +353 86 1263871 or send your CV to doconnell@berkley-group.com.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
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