MSAT Engineer

MSAT Engineer I

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With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward‑thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence, driven to bring better treatments to market efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

Abzena is more than a CDMO; we are a responsible and dedicated partner that takes care of your products from concept to patient.

• Provide support for production issue resolution and investigation with data analysis, ensuring reliable solutions, safe execution, and regulatory compliance.
• Provide in‑person and real‑time manufacturing production support required for project success.
• Adhere to all GDP, GLP, and cGMP requirements as required while fulfilling duties, responsibilities, and tasks.
• Demonstrate ownership of the equipment and process you support by being flexible, proactive, and involved; serve as a responsible engineer with deep knowledge of equipment and unit operation design characteristics and capabilities.
• Demonstrate technical proficiency, scientific creativity, leadership, and collaboration with others.

• Ability to manage multiple tasks and projects effectively with support to meet timelines.
• Accept temporary responsibilities outside of the initial job description.
• Provide training and guidance on process and technical operations to manufacturing personnel and MSAT, focusing on engineering principles.
• Collaborate in cross‑functional activities with development and manufacturing personnel, both internal and external, to support process scale‑up, technology transfer, process characterization, and process validation. Provide support to junior engineers in external discussions.
• Strong interpersonal and presentation skills with the ability to collaborate effectively, influence outcomes, and drive decisions across diverse teams and stakeholders.

• Support technology transfer into cGMP manufacturing from internal or external process development teams for downstream operations based on area of expertise.
• Plan, lead, and/or implement multiple smaller projects at the same time with support.
• Initiate and recommend improvements in process and equipment operation with support, based on sound engineering and scientific knowledge, toward increasing process robustness, efficiency, and productivity.
• Implement new equipment and process technologies in the manufacturing area; train manufacturing personnel on these technologies.

• Write, revise, review, and otherwise support the document life cycle for master batch records, BOMs, specifications, SOPs, tech transfer documents, PFDs, and P&IDs.
• Analyze, manage, and drive to completion risk assessments and facility fit for process transfer, scale‑up, and new material introduction.
• Maintain a strong working knowledge of cGMP raw materials, consumables, assemblies, in‑process materials, designs, and part numbers to complete detailed cGMP records.

• Deep knowledge and understanding of cGMPs and how they apply to duties and responsibilities.
• Knowledge and skill with aseptic technique required: BSC operations, and aseptic processing, including welding/sealing and/or single‑use sterile connectors.
• Deep knowledge of large molecule biologics such as mAb (IgG1, IgG4), Fab, IgM, Fusion, VLP, or other.
• Strong working knowledge of Tangential Flow Filtration (UF/DF) and harvest operations preferred.
• Understanding of viral clearance validation.
• Understanding of separations, clearance, and purification systems such as disk‑stack centrifugation, depth filtration chromatography (affinity, ion exchange, HIC, SEC, mixed mode), particularly using AKTA systems; viral inactivation, viral filtration, and UF/DF.
• Expertise…