Sr MSAT Engineer bei Abzena

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. This MSAT Senior Engineer is an individual who will be acting as Subject Matter Expert for Upstream Biopharmaceutical manufacturing and knowledge in Downstream operations is a plus. This role will also be critical in support of commercialization in executing PPQ and process validation activities.  The Senior Engineer will be responsible for and adhere to the following: 

Responsibilities

Adhere to all GDP, GLP, and cGMP requirements as required while fulfilling duties, responsibilities, and tasks. 

Display strong understanding of USP, 21 CFR, and ICH guidelines. 

Develop and execute PPQ and other process validation activities in support of commercialization. 

Provide technical leadership and work cross-functionally to ensure clear communication and act as a Subject Matter Expert (SME) to explain and present scientific information and data in support of company objectives and client needs. 

Analyze and manage risks assessments and facility fit for process transfer, scale up, and new material introduction. 

Lead Technology Transfer into cGMP Manufacturing from internal or external process development teams 

Create Master batch records, BOMs, Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs. 

Write, revise, review, and otherwise support the document life cycle for Quality, Development, or GMP documentation 

Resolve complex manufacturing deviations and perform in-depth investigations or GDP experiments to determine root cause. 

Provide in-person and real-time manufacturing production support required for project success. 

Proactively manage and support continuous improvement initiatives for the site and department. 

Required to cross-train on various tasks in other technical areas to support GMP manufacturing. 

Maintain a strong 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, leadership, and collaboration with others. 

Routinely collaborate with other internal departments and as needed provide direct support. 

Strong organizational and project management skills to handle multiple projects. 

Develop departmental guidelines and policies. 

Mentor and train junior engineers and associates focusing on engineering fundamentals and areas of expertise. 

Qualifications

Bachelor’s, Master’s or PhD degree that included laboratory work in a chemistry, biology, chemical engineering or related field, or comparable experience in the industry. 

Minimum7+years of experience in a PD/GMP pharmaceutical or biotech environment.  

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 

Mammalian cell culture processes such as: CHO, Hybridoma, HEK, or other non/semi-adherent cell lines preferred 

Bioreactor Systems, such as: Wave/Rocker and Stirred Tank 

Cell banking 

Large molecule biologics such as: mAb (IgG1, IgG4), fab, IgM, Fusion, VLP, orother. 

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) 

Strong understanding of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook, Teams, etc. 

Functions and graphing within Microsoft Excel required 

Strong experience with semi/fully automated manufacturing equipment 

Experience with SCADA systems preferred 

Experience with developing and executing PPQ and other process validation activities required in Upstream processing.   Experience with Downstream PPQ and process validation activities is a plus. 

Experience with process monitoring and statistical analysis software (e.g., JMP) 

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