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Job Post Details

Process Scientist Antibody Drug Conjugate - job post

GerTEK Project Management and Technical Services
4.6 out of 5 stars
Sligo, County Sligo
Full-time

Job details

Job type

  • Full-time

Location

Sligo, County Sligo

Full job description

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects.

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.

Qualifications

  • Degree in Chemistry, Biochemistry, Analytical Science or related discipline
  • Experience 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.

Job Type: Full-time

Work Location: In person

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