Process Scientist – Sligo

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

Job summary

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

You will act as a process SME for ADC manufacturing, supporting technology transfers and ongoing production. You will work with R&D and Drug Product Development to develop robust, fit-for-purpose control strategies for new products, author assessments and safety documentation, and ensure compliance with safety and regulatory

Qualifications

• Graduate degree with 3–5 years (MSc) or 2–5 years (PhD) in biopharma.
• Experience with at-scale ADC manufacturing including conjugation and fill finish.
• Understanding large molecule chemistry and protein conjugation from projects.

Responsibilities

• Leverage expertise in ADC manufacturing and process science for transfer and ongoing manufacturing.
• Collaborate with R&D and Drug Product Development to define a robust NPI process control strategy.
• Author gap assessments, fit studies, process safety and risk assessments for NPI.

Skills

ADC manufacturing

Process SME

C&Q activities

Education

Graduate degree in Chemistry/Biochemistry/Analytical Science

Job description

The role:

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

• Process Scientist ADC (Antibody Drug Conjugate)
• 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.