NPI Analytical Scientist

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTubeandLinkedIn.Job DescriptionWe are looking for an experienced NPI Analytical Scientistto join our Analytical team in Manorhamilton Road, Sligo. This position reports directly to the NPI Analytical Manager.Purpose:To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Ensure all analytical test method transfers/validations in conjunction with S&T. Provide analytical/technical support for all routine raw material, in-process and finished product testing and investigations.Responsibilities:Performing complex calculations and reporting/escalating the results of analytical testing to wider team for investigations and improvement projects, as required.Collaborating with Quality and Process teams to draft the manufacturing and cleaning cGMP procedures as per product hold times and quality requirements.Supporting the Quality and EHS teams on cGMP procedures based on FMEA and PHA.Contributing to the development of the appropriate specification documents for raw materials, In-process and finished products.Developing and changing in-house laboratory procedures as appropriate.Ensuring all analytical testing is performed in compliance with cGMP and EHS requirements.Supporting the testing of all routine raw material, in-process and finished product as per schedule and records are maintained to appropriate requirements.Ensuring all testing/transfers/investigations are completed in a timely manner.Analytical testing to support incoming method transfers to the QC department.Analytical validation and support for co-validation of methods in conjunction with S&T.Liaise with and support S&T on analytical and technical issues.Analytical support and representation at project meetings with internal and external stakeholders.Analytical and technical support to investigations.QualificationsDegree/Diploma in Science Discipline2+ years’ experience in a GMP labSolid experience in HPLC, GC & KFSolid understanding and knowledge of regulatory agencies and guidance, particularly ICH/CDER guidelines on analytical method validation.Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr