Process Scientist

PE Global; Sligo; On-site; EUR 65,000 - 90,000; Full time

Job summary

PE Global is recruiting an ADC Process Scientist for a leading biopharmaceutical company in Sligo on a 12-month initial contract. The role reports to the NPI Technical Manager and sits in Technical Operations.

The candidate will apply deep ADC manufacturing knowledge to develop and transfer robust process control strategies for new products, author technical reports, and support regulatory compliance throughout technology transfers and ongoing manufacturing.

Qualifications

• Graduate degree in Chemistry/Biochemistry/Analytical Science or related discipline.
• 3–5 years of experience with MSc or 2–5 years with PhD in biopharmaceutical industry.
• Experience with at-scale ADC manufacturing including conjugation and fill finish.
• Deep understanding of large molecule and protein conjugation chemistry.
• Desirable: experience with technology transfers to fill-finish facilities.

Responsibilities

• Leverage understanding of ADC manufacturing process as SME for technology transfers and ongoing manufacturing.
• Work 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.
• Process SME for equipment selection and C&Q activities for new equipment.
• Author scientific reports and presentations to document project status to stakeholders.
• Ensure compliance with safety, regulatory and compliance expectations.

Skills

ADC manufacturing experience

Process transfer expertise

Education

Graduate degree in Chemistry/Biochemistry/Analytical Science or related

MSc: 3–5 years experience or PhD: 2–5 years experience in biopharmaceuticals

Job description

PE Global are currently recruiting for a NPI Process Scientist for our client site in Sligo on a 12-month initial contract:

The role:

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 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.