- Leverage detailed understanding of the science behind antibody drug conjugate (ADC) manufacturing and the AbbVie 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, onboarding, and testing of 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.
- Graduate degree in Chemistry, Biochemistry, Analytical Science or related discipline with 3-5 years experience (MSc) or 2-5 years experience (PhD) in biopharmaceutical industry.
- Experience with at scale ADC manufacturing including conjugation and fill finish operations.
- Detailed understanding of the chemistry of large molecule and protein conjugation as evidenced by successful project execution
- Experience with new product introductions / technology transfers to fill finish manufacturing facility.
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Description
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube and LinkedIn .
Job Description
We are looking for an experienced ADC Process Scientist to join our team in Ballytivnan, Sligo . This is an exciting role to be part of NPI projects where you will bring your ADC expertise and work with various international stakeholders in R&D and Drug Product Development functions. As the ADC Process Scientist SME you will:
Qualifications
Additional Information
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.
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