ADC Process Scientist

PE Global; Sligo; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global is recruiting an ADC Process Scientist in Sligo, Ireland, on behalf of a leading biologics company. The role is an initial 12-month contract within Technical Operations, reporting to the NPI Technical Manager.

The successful candidate will apply detailed knowledge of ADC manufacturing, collaborate with R&D to develop robust process controls for new products, and drive technology transfers for ongoing manufacturing with a focus on safety and regulatory compliance.

Qualifications

• Graduate degree in Chemistry, Biochemistry, Analytical Science or related discipline.
• 3–5 years’ experience in biopharmaceutical industry (MSc) or 2–5 years (PhD).
• Experience with ADC manufacturing including conjugation and fill-finish operations.

Responsibilities

• Leverage understanding of ADC manufacturing and AbbVie process as SME for technology transfers and ongoing manufacturing.
• Collaborate with R&D and Drug Product Development to develop a robust, fit-for-purpose process control strategy for NPI.
• Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
• Design, onboarding, and testing of single-use assemblies for sterile ADC manufacturing.
• Provide SME input for equipment selection and C&Q activities for new equipment.
• Prepare scientific reports and presentations to document project status for internal and external stakeholders.
• Ensure compliance with safety, regulatory and compliance expectations.

Skills

ADC manufacturing

Technology transfers

Education

Chemistry/biochemistry/analytical science degree

Job description

PE Global are currently recruiting for an ADC Process Scientist on behalf of a leading biologics company in Sligo. This is an initial 12-month contract role.

• Job Dept: Technical Operations
• Reports to: NPI Technical Manager

Responsibilities:

• 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.
• Other duties as assigned.

Requirements:

• 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
• Desirable: Experience with new product introductions / technology transfers to fill finish manufacturing facility.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***