NPI Analytical Scientist

Job Description People. Passion. Possibilities.   Welcome to AbbVie!   At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.  We are now recruiting for an NPI Analytical Scientist at our Mannorhamilton Road site in Sligo on a 12 Month Fixed term contract. The purpose of this role is to provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification and plant quality and safety goals are met. In this role you will ensure all analytical test method transfers/validations in conjunction with S&T and provide analytical/technical support for all routine raw material, in-process and finished product testing and investigations.   Responsibilities : Establishing relationships with R&D and MS&T group for effective knowledge transfer and clear understanding of analytical requirements Demonstrating scientific initiative and creativity towards continuous process improvement for product quality and yield.  Performing complex calculations and reporting/escalating the results of analytical testing to wider team for investigations and improvement projects, as required. Collaborate 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. Assist in the resolution of quality problems as required. 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. Ensure all testing/transfers/investigations are completed in a timely manner. Maintain up-to-date, complete and precise records of all tests performed. Identifying of potential safety hazards in the laboratory and liaise with Lab Manager and EHS Officer to resolve. Aid in training and development of new team members. Taking equipment ownership to ensure that all test equipment is used and maintained correctly. 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. Plan and carry out analytical handovers to the QC department Qualifications Qualifications : Degree/Diploma in Science Discipline   Job/Technical Skills Solid experience in HPLC, GC, KF and Dissolution, with working knowledge of MS and XRD and other analytical techniques preferred. Understanding of pharmacopeial method (e.g. USP, EP) Be familiar with method transfer, validation and optimization with relevant experience preferred. Solid understanding and knowledge of regulatory agencies and guidance, particularly ICH/CDER guidelines on analytical method validation. Ability to use technical knowledge and apply it to real World laboratory issues to create innovative solutions.   Additional Information So, are you ready to be part of this ambitious and diverse team? Apply today!  It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. AbbVie 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, colour, 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.   AbbVie 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.