MSAT Engineer

Abzena Inc.•Bristol, PA

About The Position

The MSAT Engineer provides technical leadership and supports technology transfer from process development to GMP manufacturing. The role serves as the technical bridge between process development and manufacturing, helping ensure successful technology transfer, manufacturing readiness, and sustained process robustness for complex biologic drug conjugates. The position focuses on bioconjugation processes, including Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs), and supports development-to-clinical cGMP manufacturing operations across product lifecycle stages. The MSAT Department also supports secondary functions such as Quality Systems, process improvements, production equipment implementation, process automation, and data management. The role includes manufacturing-floor support, cGMP documentation and training, process safety, investigations, and continuous improvement. The position requires adherence to GLP and cGMP requirements and Abzena policies and includes handling, supervision, management, or other exposure to RCRA hazardous waste.

Requirements

Minimum bachelor's degree in a scientific or engineering discipline, or equivalent, with 3–5 years of experience in biopharma MSAT or technical operations focused on ADC and/or AOC processes.
Proven experience supporting both development and clinical-stage operations, 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 Microsoft Excel.
Proven ability to troubleshoot bioprocess operations and equipment.
Understanding of relevant analytical, processing, and scale-up calculations.
Proven ability to build, modify, and use digital data storage, visualization, and analysis systems or tools.
Strong interpersonal and communication skills, with the ability to work effectively with cross-functional teams and clients.

Nice To Haves

Familiarity with semi-automated or fully automated manufacturing 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 for cGMP clinical manufacturing.
Draft and maintain cGMP documentation, including BOMs, specifications, SOPs, technology transfer documents, PFDs, and P&IDs, as required for execution and readiness.
Lead or support process investigations, deviations, CAPAs, and root cause analysis related to cGMP manufacturing.
Translate OEB controls into practical manufacturing requirements for equipment, PPE, waste, and cleaning to champion process safety.
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.
Develop training content for new processes, equipment, and batch record revisions; maintain a living knowledge package for each program, including lessons learned, known failure modes, and standard responses.
Adhere to GLP and cGMP requirements and Abzena policies, procedures, and mission while performing duties.
Serve as the MSAT subject matter expert for bioconjugation processes, including ADCs and AOCs, across early development through commercial lifecycle stages.