Senior Engineer, ADC Manufacturing

Position Summary

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.

• 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.
• Acts as a liaison between Manufacturing and HSE team for the handling of high‑toxicity compounds and oversees safety of manufacturing activities.
• Owns and improves key unit operations (e.g., TFF, chromatography, conjugation reactions, solvent handling and Buffer Preparations).
• Collaborates with partners and customers, such as Automation, MSAT, HSE and Facilities to achieve site manufacturing deliverables for manufacturing production.
• Communicates and works with internal teams and clients to resolve floor issues, document revisions for successful process execution.
• Supports real‑time‑on‑the‑floor support to manufacturing teams during batch execution as necessary.
• Leads investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations.
• Assesses process performance trends using statistical tools and identifies process improvement opportunities for manufacturing robustness.
• Serves as SME during audits, including regulatory inspections.
• Evaluates and implements new technologies, raw materials, equipment, and methods to enhance process performance and safety.
• Partners with Quality Assurance, Quality Control, Supply Chain, Process Development, and Facilities to support seamless operations.

• Author and review technology transfer documents, equipment fit‑gap assessments, and batch records.
• Author and review master batch records (MBRs), SOPs, technical protocols and reports.
• Support regulatory agency responses for continued regulatory compliance and filing content (IND/IMPDs, BLAs).
• Provide technical justification for changes using risk‑based methodologies (FMEA, QbD principles).

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required.
• Advanced degree (MS/PhD) preferred.
• 7+ years of experience in biopharmaceutical MSAT, Process Engineering, or Manufacturing Sciences is required; 2–4 years of experience specifically in ADCs or complex bioconjugation processes is strongly preferred.
• Hands‑on experience with cGMP clinical or commercial manufacturing.
• Proven success in working in teams within a matrixed environment.
• Demonstrated success in tech transfers, and process scale‑up.

Technical understanding of:

• Conjugation chemistries (e.g., maleimide thiol, enzymatic, site specific)
• Purification technologies (TFF, chromatography)
• Experience handling highly potent drug linkers, highly potent active pharmaceutical ingredients (HPAPIs) and knowledge of Occupational Health Category (OHC) classifications.
• cGMP and regulatory expectations
• Competency with data analysis tools (e.g., JMP), DOE and multivariate analysis for process performance evaluations.
• Familiarity of regulatory issues pertaining to the manufacture of ADCs, large‑scale biopharmaceutical unit operations and process validations.
• Ability to interpret engineering drawings, P&IDs, and equipment manuals.
• Ability to perform risk…