MSAT Engineer, Bioconjugation & ADC/AOC Tech Transfer

Abzena; Bristol Township (Bucks County); On-site; USD 120,000 - 160,000; Full time

Job summary

Abzena seeks an experienced MSAT engineer to bridge process development and GMP manufacturing for highly potent biologics. You will lead technology transfer, author batch records, and support readiness for ADC/AOC programs across development to commercialization.

You will implement improvements, ensure compliance with GLP/cGMP, and train teams on new processes and equipment while interfacing with cross‑functional groups and external partners.

Qualifications

• Minimum Bachelor’s degree in scientific or engineering discipline with 3–5 years of experience in biopharma MSAT or technical operations focusing 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 in Excel.
• Familiarity with semi/fully automated manufacturing equipment.
• Proven ability to troubleshoot bioprocess operations and equipment.

Responsibilities

• Provide technical leadership for technology transfer from internal or external process development teams into cGMP manufacturing, including facility fit assessments, scale‑up planning, and risk assessments.
• 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, as required to support execution and readiness.
• 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 for equipment, PPE, waste, and cleaning.
• Provide in‑person and real‑time manufacturing production support required 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, new equipment, and new batch record revisions.
• Adhere to all GLP, and cGMP requirements as well as Abzena policies, procedures, and mission while fulfilling duties, responsibilities, and tasks.
• Serve as the MSAT subject matter expert (SME) for bioconjugation processes including ADCs and AOCs across early development through commercial lifecycle stages.

Skills

MSAT experience

Bioconjugation

Interpersonal communication

Problem solving

Education

Bachelor's degree in scientific or engineering

Tools

TFF

Protein A

IEX

HIC

Excel

Job description

Abzena seeks an experienced MSAT engineer to bridge process development and GMP manufacturing for highly potent biologics. You will lead technology transfer, author batch records, and support readiness for ADC/AOC programs across development to commercialization.

You will implement improvements, ensure compliance with GLP/cGMP, and train teams on new processes and equipment while interfacing with cross‑functional groups and external partners.