MSAT Bioconjugation Engineer (ADC/AOC) - Tech Transfer

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 90,000 - 135,000; Full time

Job summary

Abzena is seeking an experienced MSAT engineer to support technology transfer of bioconjugation processes (ADC/AOC) into cGMP manufacturing. You will lead transfer activities, compile batch records, and ensure robust, compliant operations across the product lifecycle with a focus on potency and quality.

You will collaborate with cross-functional teams, troubleshoot processes and equipment, and drive continuous improvement to meet project milestones and regulatory expectations.

Qualifications

• Minimum Bachelor’s degree in scientific or engineering discipline or equivalent with 3-5 years of experience in biopharma MSAT or technical operations with a focus on ADC and/or AOC processes.
• Proven track record in development and clinical-stage support, including batch record authorship and process documentation.
• Working knowledge of GMP operations, including manufacturing floor support, deviation resolution, and change control.
• Hands-on experience with conjugation chemistries, tangential flow filtration (TFF), Protein A, ion exchange (IEX), and hydrophobic interaction chromatography (HIC).
• Strong understanding of Microsoft Office Suite including basic functions and graphing within Microsoft Excel
• Familiarity with semi/fully automated manufacturing equipment
• Proven ability to troubleshoot bioprocess operations and equipment.
• Understanding of relevant analytical, processing, and scale-up calculations.
• Proven ability to build, modify, and utilize digital data storage, visualization, and analysis systems/tools.
• Strong interpersonal and communication skills, with the ability to interface effectively with cross-functional teams and clients

Responsibilities

• Provide technical leadership for technology transfer from internal or external process development teams into cGMP manufacturing.
• Lead transfer of bioconjugation processes into cGMP manufacturing from internal teams and external development partners.
• Author and revise batch records and master batch production documents to support cGMP clinical manufacturing.
• Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P&IDs.
• Lead or support process investigations, deviations, CAPAs, and root cause analysis related to cGMP manufacturing.
• Champion process safety by translating OEB controls into practical manufacturing requirements.
• Provide in-person and real-time manufacturing production support for project success.
• Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
• Technical training and knowledge management. Develop training content for new processes, equipment, and batch record revisions.
• Adhere to GLP and cGMP requirements and Abzena policies.
• Serve as the MSAT SME for bioconjugation processes across lifecycle stages.

Skills

Bioconjugation

ADC/AOC

GMP knowledge

Tech transfer

Documentation

Troubleshooting

Cross-functional teamwork

Education

Bachelor's degree in science/engineering

Tools

TFF

Protein A

IEX

HIC

Microsoft Excel

Job description

Abzena is seeking an experienced MSAT engineer to support technology transfer of bioconjugation processes (ADC/AOC) into cGMP manufacturing. You will lead transfer activities, compile batch records, and ensure robust, compliant operations across the product lifecycle with a focus on potency and quality.

You will collaborate with cross-functional teams, troubleshoot processes and equipment, and drive continuous improvement to meet project milestones and regulatory expectations.