Senior Engineer, ADC Manufacturing

The Senior Engineer, ADC Manufacturing is an individual contributor that serves as a technical SME for antibody drug conjugate (ADC) manufacturing processes across clinical and commercial programs. This role provides subject matter expertise in conjugation chemistry, purification, scaleup, and technology transfer. The Senior Engineer drives process robustness, investigates deviations, implements process improvements, and ensures that manufacturing operations comply with cGMP standards. The ideal candidate combines hands-on technical skills with strategic influence across cross-functional teams, will identify best practices and provide technical trainings.

Duties & Responsibilities

Technical Leadership

• Serves as the primary technical authority for ADC conjugation, formulation, and purification processes across multiple development stages.
• Leads technical transfers of ADC processes for First in Human, scale up, late-stage, Validation activities and design of Critical Process Parameter readiness.
• Supports a high-performing technical team through effective communication and mentoring of junior engineers.
• Develops and maintains process descriptions, process flow diagrams, and process models.
• Act as a liaison between Manufacturing and HSE team for the handling of High toxicity compounds and oversees safety of manufacturing activities.
• Own and improve key unit operations (e.g., TFF, chromatography, conjugation reactions, solvent handling and Buffer Preparations).
• Collaborate with partners and customers, such as Automation, MSAT, HSE and Facilities to achieve site manufacturing deliverables for manufacturing production.
• Communicates and work with internal teams and clients to resolve on the floor issues, document revisions for successful process execution.
• Supports real time-on-the-floor support to manufacturing teams during batch execution as necessary.
• Lead investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations.
• Assess process performance trends using statistical tools and identify process improvement opportunities for manufacturing robustness.
• Serve as SME during audits, including regulatory inspections.
• Evaluate and implement new technologies, raw materials, equipment, and methods to enhance process performance and safety.
• Partner with Quality Assurance, Quality Control, Supply Chain, Process Development, and Facilities to support seamless operations.

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