Company Overview
AbbVie aims to discover and deliver innovative medicines and solutions addressing significant health issues today and in the future. We focus on several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio.
Job Summary
We seek an ADC Process Scientist to join our team in Sligo, Ballytivnan. This role is part of an important NPI project where you will leverage your expertise in antibody drug conjugate manufacturing and collaborate with international stakeholders in R&D and Drug Product Development functions.
Responsibilities
* Utilize detailed understanding of the science behind antibody drug conjugate manufacturing and AbbVie's manufacturing process as manufacturing plant-based Process Scientist SME for technology transfers and ongoing manufacturing.
* Work with Research & Development and Drug Product Development functions to develop and transfer a well-understood, robust, fit-for-purpose process control strategy for each new product introduction (NPI).
* Author gap assessments, facility fit studies, process safety, and risk assessments for NPI.
* Design, onboard, and test single-use assemblies for use in sterile manufacturing of ADC.
* Process SME for equipment selection and C&Q activities for any new equipment.
* Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
* Understand and ensure compliance with safety, regulatory, and compliance expectations.
Qualifications
* Degree in Chemistry, Biochemistry, Analytical Science, or related discipline with 3-5 years of experience/MSc with 2-5 years of experience/PhD in the biopharmaceutical industry.
* Experience with at-scale ADC manufacturing, including conjugation and fill-finish operations.
* Detailed understanding of the chemistry of large molecules and protein conjugation as evidenced by successful project execution.
* Experience with new product introductions / technology transfers to fill-finish manufacturing facilities.
About Us
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We aim to employ qualified individuals without discrimination based on protected characteristics.