MSAT Engineer
The MSAT (Manufacturing Science and Technology) Department at Abzena provides technical leadership and supports technology transfer activities from Process Development to GMP Manufacturing. Additionally, MSAT is a key stakeholder for multiple secondary functions including support of Quality Systems, Process Improvements, Production Equipment Implementation, Process Automation, Data Management, etc.
We are seeking an experienced and highly skilled engineer with expertise in bioconjugation processes, including Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs), to support development-to-clinical cGMP manufacturing operations. You will serve as the MSAT technical bridge between process development and manufacturing, ensuring successful technology transfer, manufacturing readiness, and sustained process robustness for highly potent and complex biologic drug conjugates across the product lifecycle.
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. Maintain a living knowledge package per program, including lessons learned, known failure modes, and standard responses.
- 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.
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 both 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
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
This job description requires the handling, supervision, management, or otherwise exposure to RCRA hazardous waste as defined at 40 CFR (Code of Federal Regulations), parts 239 – 289.
