Senior Engineer, Bioconjugation Operations

Mantell Associates is partnered with a leading global CDMO, who are searching for a Senior Engineer, Bioconjugation Operations to join their organisation on site in New York.

Senior Engineer, Bioconjugation Operations – Responsibilities:

• Act as the lead technical subject matter expert for antibody-drug conjugate (ADC) conjugation, purification and formulation processes across clinical and commercial programmes
• Lead technology transfers into the site, supporting first-in-human, scale-up, late-stage and process validation activities, including definition of Critical Process Parameters
• Own and optimise key unit operations including conjugation reactions, TFF, chromatography, solvent handling and buffer preparation
• Provide hands-on, real-time support to Manufacturing during batch execution, resolving on-the-floor issues alongside internal teams and clients
• Lead deviation investigations, root cause analysis and CAPA development, driving cross-functional investigations through to closure
• Analyse process performance trends using statistical tools to identify opportunities to improve robustness, safety and efficiency
• Author and review technology transfer documentation, fit-gap assessments, master batch records, SOPs, protocols and technical reports
• Act as technical SME during client audits and regulatory inspections, and support regulatory filings and agency responses (IND/IMPD, BLA)
• Partner with HSE on the safe handling of highly potent compounds, and collaborate with Quality, MSAT, Process Development, Automation, Supply Chain and Facilities
• Mentor junior engineers and manufacturing personnel, delivering technical training and sharing best practice

Senior Engineer, Bioconjugation Operations – Requirements:

• Bachelor’s degree in Chemical Engineering, Chemistry, Biology or a related discipline; MS or PhD preferred
• 7+ years’ experience in biopharmaceutical MSAT, Process Engineering or Manufacturing Sciences, ideally including 2–4 years focused on ADCs or complex bioconjugation
• Strong technical knowledge of conjugation chemistries (e.g. maleimide-thiol, enzymatic, site-specific) and purification technologies (TFF, chromatography)
• Experience handling highly potent drug-linkers and HPAPIs, with an understanding of OHC classifications and containment strategies
• Proven track record in technology transfer and process scale-up within a cGMP clinical or commercial manufacturing environment
• Proficiency with data analysis tools (e.g. JMP), DOE and multivariate analysis, alongside risk-based approaches such as FMEA and QbD
• Ability to interpret P&IDs, engineering drawings and equipment documentation
• Excellent communication and technical writing skills, with confidence facilitating discussions across teams and with clients
• Comfortable working in classified cleanroom environments (gowning, PPE/PAPR) within a fast-paced, matrixed organisation
• Based in or willing to relocate to New York, with the ability to work fully on site

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.