MSAT Engineer

Abzena•Bristol, PA

About The Position

Abzena’s Manufacturing Science and Technology (MSAT) Department provides technical leadership and supports technology transfer from Process Development to GMP Manufacturing, while also supporting Quality Systems, process improvements, production equipment implementation, process automation, and data management. The MSAT Engineer serves as the technical bridge between process development and manufacturing, supporting development-to-clinical cGMP manufacturing operations for complex biologic drug conjugates, including Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs). The role helps ensure successful technology transfer, manufacturing readiness, and sustained process robustness across the product lifecycle. The position provides technical leadership for bioconjugation processes from early development through commercial lifecycle stages. It includes transfer planning and execution, cGMP documentation, manufacturing-floor support, process troubleshooting and investigation, process safety, continuous improvement, and technical training. The role requires adherence to GLP and cGMP requirements and Abzena policies and procedures. The job requires handling, supervision, management, or other exposure to RCRA hazardous waste as defined at 40 CFR, parts 239–289. Abzena states that it is an equal opportunity employer committed to workplace diversity and inclusion and prohibits discrimination and harassment based on protected characteristics.

Requirements

Minimum bachelor’s degree in a scientific or engineering discipline, or equivalent.
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 work, 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 interface 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 bills of materials (BOMs), specifications, SOPs, technology transfer documents, process flow diagrams (PFDs), and piping and instrumentation diagrams (P&IDs).
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, real-time manufacturing production support as needed for project success.
Drive continuous improvement initiatives related to process robustness, documentation, and manufacturing efficiency.
Develop technical 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 carrying out duties.
Serve as the MSAT subject matter expert for bioconjugation processes, including ADCs and AOCs, from early development through commercial lifecycle stages.