Senior Engineer, Bioconjugation Operations

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Position Summary

The Senior Engineer, Bioconjugation Operations serves as a technical subject matter expert (SME) supporting bioconjugation, ADC, and related manufacturing processes across clinical and commercial programs. This role provides expertise in bioconjugation chemistry, antibody purification, process engineering, technology transfer, scale-up manufacturing, process optimization, and cGMP operations. The Senior Engineer drives and supports process deviation investigations, implements process improvements, and ensures manufacturing operations are compliant with cGMP standards. The ideal candidate combines strong hands-on technical expertise with the ability to influence cross-functional teams, identify and implement best practices, and deliver technical training to support operational excellence.

Duties & Responsibilities

Technical Leadership

• Serves as technical SME for bioconjugation and ADC manufacturing processes, including conjugation, formulation, and purification, across multiple development stages.
• Leads technology transfer and scale-up activities for bioconjugation and ADC processes supporting First-in-Human, late-stage, validation, and commercial manufacturing readiness.
• Provides technical leadership through effective communication, knowledge sharing, and mentoring of junior engineers and manufacturing personnel.
• 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, formulation, solvent handling, and buffer preparation).
• Collaborates with cross-functional teams, including Manufacturing, MSAT, Automation, HSE, Facilities, and external clients to achieve production and operational objectives.
• Communicates and works with internal teams and clients to resolve manufacturing issues, support document revisions, and ensure successful process execution.

Provides real-time floor support to manufacturing teams during batch execution as needed.

• Leads investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations.
• Assesses process performance trends using statistical tools and identify process improvement opportunities for manufacturing robustness.
• Serves as SME during audits, including regulatory inspections.
• Evaluates and implement 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.
• Supports successful introduction of new products and technologies into manufacturing through process readiness assessments, risk evaluations, and cross-functional planning activities.

Documentation & Technical Writing

• Author and review technology transfer documentation, equipment fit-gap assessments, batch records, and process support documentation.
• 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).

Education & Experience

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required.
• Advanced degree (MS/PhD) preferred.
• 7+ years of experience in biopharmaceutical manufacturing, process engineering, MSAT, technology transfer or manufacturing sciences is required. Experience with ADCs, bioconjugation processes, HPAPIs, or related complex manufacturing technologies is strongly preferred.