Process Scientist

Collins McNicholas Recruitment; Sligo; On-site; EUR 60,000 - 90,000; Full time

Job summary

Collins McNicholas Recruitment seeks a Process Scientist for an ADC-focused role with a pharmaceutical client in Sligo. This 12-month temporary contract involves working within the Antibody Drug Conjugate team and applying deep knowledge of ADC manufacturing and tech transfers.

You will collaborate with R&D and Drug Product Development to ensure robust processes for new product introductions, and author risk assessments, safety studies, and technical documentation for stakeholders.

Qualifications

• 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.

Responsibilities

• Leverage understanding of ADC manufacturing and transfer processes as SME for tech transfers and ongoing manufacturing.
• Collaborate with R&D and Drug Product Development to develop robust process control strategies for NPIs.
• 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.
• Act as subject matter expert for equipment selection and C&Q activities for new equipment.
• Author scientific reports and presentations to document project status for stakeholders.

Skills

ADC manufacturing

Process transfers

Documentation

Risk assessment

Education

MSc in Chemistry/Analytical Science

PhD in related field

Job description

We are working with a pharmaceutical client in Sligo to recruit a Process Scientist to join their Antibody Drug Conjugate team on a temporary, 12 month contract.

Responsibilities:

• Leverage detailed understanding of the science behind antibody drug conjugate (ADC) manufacturing and the client'smanufacturing 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.

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.