Manufacturing Data Scientist
At SAB Biotherapeutics (SAB), we’re using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that’s global + personal. Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
As a member of the bioprocessing and manufacturing team for human health antibody therapeutics, this person’s primary role will be to understand various bioprocessing, purification, and manufacturing tasks, and perform data recording, data collection, data summarization, data analysis, graphing and reporting data associated with purifying and isolating polyclonal antibody therapeutics, from bovine plasma to final drug product. The ideal candidate will be familiar with and work within all regulatory requirements of a cGMP environment related to aseptic bioprocessing, filling and labeling in accordance to the Food and Drug Administration. However, candidates who do not have FDA cGMP experience but who are familiar with and have experience in process- and specification-driven manufacturing and fabrication that results in the data collection and subsequent analysis and reporting will be evaluated. Candidates who have experience working within any Quality-driven environment that adheres to good documentation practices will also be considered. Familiarity and experience in working with various software programs associated with data collection, graphing and analysis, as well as Excel and Powerpoint is an advantage, regardless of industry.
Essential Duties and Responsibilities:
- Able to create standard operating procedures related to data analysis
- Collect, transcribe and summarize data from batch records, instruments, databases, and other forms of data warehousing in a cGMP and Quality setting that is regulated by the FDA
- Develop solutions to analyzing and visualizing data coming from various manufacturing and assay platforms.
- Perform data reduction and reporting activities and provide support to bioprocessing of bovine plasma and antibody therapeutic drug processing from upstream thru downstream processes, completing at clinical fill/finish manufacturing operations. Identify and subsequently participate in troubleshooting, root cause analysis, and product impact assessments for non-conformance data and their investigations and process/changes and improvements as may be needed
- Participate in cross-functional teams to drive alignment and manufacturing efficiency
- Operate in a clean room ISO 8 and ISO 7 areas and perform aseptic gowning for ISO 5 areas
- Able to gather data off of bioprocessing equipment
- Interact with Quality Assurance and Quality Control to solve any quality issues that may arise
- Assist others when needed
Experience with bioprocessing of biologic material (microbiology, bioreactors, purification, chromatography, etc) for active product purification is preferred. Familiarity of cGMPs, regulatory guidance documents, data analysis techniques is an advantage.
Edcation, Experience and Certifications:
- Bachelor of Science, Master of Science, or PhD degree in a science field (Biology, Microbiology, Biotechnology, Engineering, Computer Science, Finance, Analytics, Mathematics)
- 2 – 3 years minimum direct experience required.
- Ability to learn and act in a dynamic environment
- Individual must possess record keeping and organizational skills
Individual should possess strong communication skills and proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook) as well as the ability to effectively present information in one-on-one and small groups.
Basic mathematical skills to consist of addition, subtraction, multiplication and division.
While performing the duties of this job, the employee is regularly required to walk, stand and sit. Specific vision abilities required by this individual include close vision, peripheral vision, and the ability to adjust focus. The employee will view a computer monitor for long periods of time.
Physical Requirements/Working Conditions: Ability to lift 50 pounds, be on feet walking or standing for extended periods of time as needed. Ability to lift over 100 pounds by mechanical means.
Duties will be performed in a clean room environment (ISO 8, 7, and 5) and normal office setting.
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.