Job Description We are currently hiring an Analytical Technology Scientist to join out team in Westport on a 23 month Fixed Term Contract.
This role supports (as required) the transfer and validation of new assays introduced to the Westport NPI QC Bioassay laboratory and continuous improvement of the existing methods.
This role will lead and/or support generation of documentation (protocols and reports), ensuring that our methods conform to Regulatory requirements. The Analytical Technology Scientist will have extensive knowledge and experience of Bioassays, Cell Culture, ELISAs driving all laboratory related Root Cause Investigations (RCAs), and opportunities for improvement.
The Scientist will liaise and maintain clear communication with cross-functional SMEs within the network.
Provide motivation to the team and take appropriate action when method/individual performance requires intervention.
Participate and as required, lead SME meetings based on method transfer/validation/RCA requirement.
Maintain and development SME contacts within the organization to ensure methods are performing optimally Support updates to key stakeholders on project and method timelines to support project completion on time, or highlighting challenges to the timeline Attend departmental and Tier meetings, Safety Gemba.
Support development of key talent as part of succession planning Attend any other meeting as directed by area manager Provide review and approval of local and corporate documents Support the NPI and Commercial QC Bioassay teams in any RCA or continuous improvement projects/initiatives Host and represent the QC Bioassay department in any SME or project related meetings Develop and execute all project related documentation (protocol & reports), ensuring any activity executed is in line with GMP and Reg requirements Qualifications MSc and/or PhD in Relevant Biologics field with 3-5 years GMP experience Mammalian Cell Culture experience Project Management and report writing Method development, transfer, validation, and cross validation per GMP Regulations RCA, continuous improvement Ability to communicate data clearly and concisely to Snr.
Management Additional Information AbbVie 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.
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