MSAT Associate II

Abzena Inc.•San Diego, CA

5d•$70,000 - $90,000

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 Associate is an individual who will be acting as Technical Support primarily for buffer/media formulations and identifying and authoring material specifications for GMP use and secondarily for supporting either Upstream or Downstream Biopharmaceutical manufacturing. The Associate will be responsible for and adhere to the following

Requirements

BA/BS degree in chemistry, biology, chemical engineering or related field or comparable experience in industry.
Minimum 3 to 4 years of experience with a BA/BS degree or 7+ years of experience with a high school diploma in a pilot-scale or GMP manufacturing role in the pharmaceutical or biotech industry. With a BA/BS degree, equivalent years of experience in an academic laboratory is acceptable if work included experience in Upstream or Downstream categories listed below.
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
Knowledge of cleanroom operations and proper gowning techniques
Knowledge of Media and/or Solution Preparation: acid/base conjugates, buffer titration, and formulation analysis techniques (e.g., pH, conductivity, osmolarity)
Strong understanding of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook, Teams, etc.
Basic functions and graphing within Microsoft Excel required
Familiarity with semi/fully automated manufacturing equipment preferred
Familiarity with SCADA systems preferred
Understanding of USP, 21 CFR, and ICH guidelines preferred

Nice To Haves

Knowledge in any of the following Upstream or Downstream categories is a plus:
Upstream:
Mammalian cell culture processes. Experience with CHO, Hybridoma, HEK, or other non/semi-adherent cell lines preferred
Working knowledge of cell bank generation, maintenance, initial thaw and analysis (e.g., viability and viable cell density)
Working knowledge of cell passaging and expansion
Working knowledge of Single-Use Bioreactor Systems, such as: Wave/Rocker and Fed-Batch
Downstream
Large molecule biologics such as: mAb (IgG1, IgG4), fab, IgM, Fusion, VLP, or other.
Intermediate level technical knowledge of at least one, and operational knowledge of at least one additional, Separations, Clearance, and Purification Systems, such as:
Disk Stack Centrifugation and Depth Filtration
Chromatography (Affinity, Ion Exchange, HIC, SEC, Mixed Mode), using ÃKTA systems
Tangential Flow Filtration (UF/DF) operations and systems
Viral Inactivation and Viral Filtration principles and techniques
Single Use Buffer/ Solution Preparation

Responsibilities

Adhere to all GDP and cGMP requirements as required while fulfilling duties, responsibilities, and tasks.
Provide technical support for active GMP production for their assigned unit operation(s) and to explain and present scientific information and data in support of this.
Support and analyze risk assessments and facility fit for process transfer, scale up, and new material introduction.
Support Technology Transfer into cGMP Manufacturing from internal or external process development teams for assigned unit operation.
Create Master Batch Records, Bill of Materials, Material Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs in support of assigned unit operation.
Subject Matter Expert of Buffer/Media Formulation and journeyman experience in Upstream or Downstream operations.
Write, revise, review, and otherwise support the document life cycle for Quality, Development, or GMP documentation.
Support manufacturing deviations and implement assigned CAPA actions.
Provide in-person and real-time GMP production support required for project success.
Identify and support continuous improvement initiatives for the site and department.
Required to cross-train on various tasks in other technical areas to support technology transfer activities.
Develop working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records.
Demonstrates technical proficiency, scientific creativity, and collaboration with others.
Routinely collaborate with other internal departments and provide direct support, as needed.