Job Title: Process Scientist – Antibody Drug Conjugate (ADC)
Responsibilities
- Act as the subject matter expert (SME) for antibody drug conjugate (ADC) manufacturing processes at the plant level, supporting technology transfers and ongoing manufacturing activities.
- Collaborate with R&D and Drug Product Development teams to develop and transfer robust, fit-for-purpose process control strategies for new product introductions (NPI).
- Conduct and author gap assessments, facility fit studies, process safety analyses, and risk assessments for NPI projects.
- Lead the design, onboarding, and validation of single-use assemblies for sterile ADC manufacturing.
- Serve as the process SME for equipment selection and commissioning & qualification (C&Q) of new manufacturing equipment.
- Prepare scientific reports, technical documentation, and presentations to communicate project progress to internal and external stakeholders.
- Ensure adherence to safety protocols, regulatory guidelines, and compliance standards.
- Perform additional duties as assigned.
Requirements
- Graduate degree (MSc or PhD) in Chemistry, Biochemistry, Analytical Science, or a related field.
- MSc with 3–5 years or PhD with 2–5 years of experience in the biopharmaceutical industry.
- Hands-on experience with scaled ADC manufacturing processes, including conjugation and fill-finish operations.
- Strong knowledge of large molecule and protein conjugation chemistry, demonstrated through successful project delivery.
- Desirable: Experience with new product introductions and technology transfers to fill-finish manufacturing facilities.
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