Senior Engineer, Bioconjugation Operations

Mantell Associates; New York (NY); On-site; USD 130,000 - 170,000; Full time

Job summary

Mantell Associates, partnered with a leading global CDMO, seeks a Senior Engineer for Bioconjugation Operations in New York. The role is on-site and focuses on ADC conjugation, purification and formulation across programmes.

You will lead transfers, optimize unit operations, and support regulatory interactions while mentoring junior engineers in a fast-paced environment.

Qualifications

• Lead ADC conjugation and purification across clinical and commercial programmes.
• Transfer technology into the site, defining CPP and supporting scale-up.
• Strong cross-functional collaboration to optimise unit operations (conjugation, TFF, chromatography).

Responsibilities

• Act as lead SME for ADC conjugation, purification and formulation.
• Lead technology transfers and support first-in-human, scale-up and process validation.
• Own and optimise conjugation, TFF, chromatography, solvent handling and buffer prep.

Skills

Conjugation chemistries

Process scale-up

Data analysis (JMP, DOE)

Education

Bachelor’s in Chemical Engineering, Chemistry, or Biology

Tools

JMP

Job description

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-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