Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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.

Qualifications

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

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html