ADC (Antibody Drug Conjugate) Process Scientist

Sterling Engineering

Sligo

On-site

EUR 90,000 - 130,000

Full time

7 days ago
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Job summary

Sterling Engineering is seeking an experienced Process Scientist SME for ADC manufacturing. You will lead process development, support technology transfers, and ensure robust manufacturing for new product introductions. You will collaborate with R&D, DP Development, and cross-functional teams to deliver scalable, compliant processes.

The role requires strong GMP experience, outstanding technical writing, and the ability to communicate complex biopharma science to stakeholders across functions.

Qualifications

  • MSc with extensive biopharmaceutical manufacturing exposure.
  • PhD acceptable with relevant experience in ADCs.

Responsibilities

  • Act as the Process Scientist SME for ADC manufacturing and tech transfers.
  • Support NPI and ongoing manufacturing activities with robust processes.
  • Develop control strategies for new product introductions.
  • Contribute to risk assessments, facility fit studies and C&Q planning.
  • Prepare high-quality technical reports and communicate results to stakeholders.

Skills

ADC manufacturing
Process development
Technology transfer
Biopharmaceutical manufacturing
GMP experience
Analytical science

Education

MSc in Chemistry/Biochemistry/Analytical Science
PhD in a related field

Job description

Job Description

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 35 years' experience in the biopharmaceutical industry; or PhD in a relevant scientific discipline with approximately 25 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.

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