Our client, a leader in the Pharmaceutical Industry, is seeking a Process Scientist ADC to join their team based in their Sligo facility.
Responsibilities:
1. 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.
2. 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).
3. Author gap assessments, facility fit studies, process safety, and risk assessments for NPI.
4. Design, onboarding, and testing of single use assemblies for use in sterile manufacturing of ADC.
5. Process SME for equipment selection and C&Q activities for any new equipment.
6. Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
7. Understand and ensure compliance with safety, regulatory, and compliance expectations.
8. Other duties as assigned.
Requirements:
1. Graduate degree in Chemistry, Biochemistry, Analytical Science, or related discipline with 3-5 years experience (MSc) or 2-5 years experience (PhD) in the biopharmaceutical industry.
2. Experience with at scale ADC manufacturing including conjugation and fill finish operations.
3. Detailed understanding of the chemistry of large molecule and protein conjugation as evidenced by successful project execution.
4. Desirable: Experience with new product introductions / technology transfers to fill finish manufacturing facility.
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