ADC (Antibody Drug Conjugate) Process Scientist

Our client is seeking an experienced Process Scientist – ADC (Antibody Drug Conjugate) to join their Technical Operations team.

This is an exciting opportunity for a scientifically driven professional with experience in ADC manufacturing, process development and technology transfer to play a key role in the successful introduction and ongoing manufacture of new products.

As the manufacturing plant-based Process Scientist Subject Matter Expert (SME), you will provide scientific and technical leadership across new product introductions (NPI), technology transfers and ongoing manufacturing activities. You will work closely with Research & Development, Drug Product Development and cross-functional technical teams to ensure processes are robust, well understood and fit for purpose.

Key Responsibilities

• Act as the manufacturing plant-based Process Scientist SME for ADC manufacturing, supporting technology transfers, new product introductions and ongoing manufacturing activities.
• Apply a detailed understanding of ADC manufacturing science and processes to support successful product introduction and commercial manufacturing.
• Work closely with Research & Development and Drug Product Development teams to develop and transfer robust, well-understood and fit-for-purpose process control strategies for new product introductions.
• Author and contribute to gap assessments, facility fit studies, process safety assessments and risk assessments for new product introductions.
• Lead the design, onboarding and testing of single-use assemblies for sterile ADC manufacturing.
• Provide process SME input into equipment selection, commissioning and qualification (C&Q) activities for new equipment.
• Prepare high-quality scientific reports, technical documentation and presentations to communicate project progress, technical conclusions and recommendations to internal and external stakeholders.
• Work collaboratively with cross-functional teams to identify and resolve technical and manufacturing challenges.
• Ensure all activities are conducted in accordance with applicable safety, regulatory, quality and compliance requirements.
• Support additional technical and project activities as required.

About You

The successful candidate will have a strong scientific background combined with practical experience in biopharmaceutical manufacturing, ideally within Antibody Drug Conjugates (ADC).

Essential Requirements

• MSc in Chemistry, Biochemistry, Analytical Science or a related scientific discipline, with approximately 3–5 years' experience in the biopharmaceutical industry; or
• PhD in a relevant scientific discipline with approximately 2–5 years' industry experience.
• Demonstrable experience in at-scale ADC manufacturing, including conjugation and fill-finish operations.
• Strong understanding of the chemistry of large molecules, proteins and protein conjugation, supported by successful hands-on project execution.
• Experience working in a GMP biopharmaceutical manufacturing environment.
• Strong scientific, analytical and problem-solving skills.
• Excellent technical writing and communication skills, with the ability to communicate complex scientific information to a range of stakeholders.
• Ability to work effectively across multidisciplinary and cross-functional teams.

Desirable Experience

• Experience supporting New Product Introductions (NPI).
• Previous experience with technology transfers into a fill-finish manufacturing facility.
• Experience with single-use technologies and assemblies in sterile manufacturing.
• Experience supporting equipment selection and commissioning and qualification (C&Q) activities.

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose