Scientist II

12-month Fixed Term Contract | AbbVie Westport

Join AbbVie in Westport and contribute to the development and delivery of innovative medicines that make a meaningful difference to patients. This 12-month fixed term contract offers an exciting opportunity to work within the Product Development, Science & Technology (PDS&T) team, supporting new product introductions and analytical method lifecycle activities in a collaborative, science-driven environment.

 

Role Purpose

The Scientist II, PDS&T Analytical will lead and support the development, qualification, validation, and transfer of analytical methods, primarily ELISA, HPLC, and related assays, to support New Product Introductions (NPIs) at AbbVie Westport. This role ensures methods are scientifically robust, compliant with applicable regulatory and quality requirements, and effectively integrated into production and QC workflows to support clinical and commercial supply.

The successful candidate will also support NPI product leads and lifecycle management activities, including stability and specification documentation, data trending, third-party method transfers, sample coordination, reagent requalification, and procurement support. In addition, this role will support QC activities through coordination of release and stability samples, investigation support, and cross-functional collaboration.

Key Responsibilities

• Lead and/or support the development, qualification, validation, and transfer of analytical methods, with a focus on HPLC and ELISA, for new product introductions.
• Apply Quality by Design principles to ensure methods are scientifically sound, GMP compliant, and suitable for QC implementation.
• Support technology transfer activities from R&D to manufacturing and QC, ensuring smooth handover and minimal disruption to operations.
• Plan, execute, and track analytical projects related to method development, validation, and transfer to ensure timely delivery of project milestones.
• Prepare, review, and maintain technical documentation, including protocols, reports, specifications, stability documentation, and SOPs.
• Support NPI product leads with analytical data compilation, trending, stability and specification updates, sample shipment coordination, reagent requalification, and procurement-related activities.
• Coordinate release and stability sample activities in partnership with QC and other cross-functional stakeholders.
• Support and participate in investigations, troubleshooting, and root cause analysis related to analytical methods and testing.
• Collaborate closely with R&D, QC, Manufacturing, Regulatory Affairs, and Quality to resolve technical challenges and support project execution.
• Train and support QC and cross-functional team members in the transfer and execution of new analytical methods, as appropriate.

Required Education and Experience

• B.Sc. in a relevant scientific discipline with at least 7 years of relevant experience, or
• M.Sc. in a relevant scientific discipline with at least 5 years of relevant experience, or
• PhD in a relevant scientific discipline with at least 2 years of relevant experience

Required Skills and Experience

• Experience in analytical method development, validation, and transfer, preferably within a regulated pharmaceutical or biopharmaceutical environment.
• Proficiency in chromatographic techniques, including HPLC.
• Proficiency in bioassay techniques, including ELISA.
• Strong knowledge of GMP, ICH guidelines, and regulatory requirements for analytical methods.
• Demonstrated ability to lead complex projects and work effectively with cross-functional teams.
• Strong troubleshooting and problem-solving skills with a proven ability to identify and resolve technical issues.
• Excellent written and verbal communication skills, with the ability to communicate complex scientific information clearly to diverse audiences.
• Strong interpersonal and collaboration skills, with the ability to work effectively in a team-based environment.
• Understanding of the drug development process, including regulatory submissions such as IND and NDA.

Preferred Qualifications

• Experience supporting New Product Introductions in a GMP manufacturing environment.
• Experience with Quality by Design approaches in analytical method development.
• Experience training others and supporting method handover to QC.
• Exposure to method transfers to third-party laboratories.
• Experience implementing new technologies or analytical approaches in a regulated environment