MSAT Engineer I

Abzena Inc.•San Diego, CA

5d•$110,000 - $125,000

About The Position

With extensive experience in developing biologics and bioconjugates, we offer 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. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The MSAT (Manufacturing Science and Technology) Department at Abzena provides technical leadership and supports technology transfer activities from Process Development to GMP Manufacturing. MSAT also plays a role in multiple secondary functions, in support of Quality Systems, Process Improvements, Production Equipment Implementation, Process Automation, Data Management, etc. The MSAT Engineer II is an individual who will be acting as Subject Matter Expert for either Upstream or Downstream Biopharmaceutical manufacturing. The Engineer will be responsible for and adhere to the following:

Requirements

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
Expertise in the following Downstream categories: 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 is 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, Tangential Flow Filtration (UF/DF).
Expertise in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook, Teams, Visio, Smartsheet etc.
Functions and graphing within Microsoft Excel required
Experience with semi/fully automated manufacturing equipment
Experience with SCADA systems is preferred
Should understand basic statistical methods and their application in tech transfer and product lifecycle.

Responsibilities

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 to process by possessing a deep knowledge of equipment and unit operation design characteristics and capabilities.
Demonstrates 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 initial job description.
Provide training and guidance on process and technical operations to manufacturing personnel and MSAT, with a focus 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 manufacturing area with support and 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