Downstream Purification Engineer
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 schedule, train, and perform various equipment and manufacturing validation tasks 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 validation protocols, validation, and process-driven testing will be evaluated and considered.
Essential Duties and Responsibilities:
Develop documentation and perform/lead activities associated with Process Validation using various FDA Guidance documents.
- Scope, author, develop, and implement site Validation Master Plans
- Support the development of the Process Performance Qualification and associated components related to Process Validation
- Develop, author and implement various Process Validation Plans associated with the bioprocessing and manufacturing requirements.
- Technical resource needed to help with the design, development, evaluation, or troubleshooting of validation processes, testing procedures, change control, or other systems, with regards to process validations.
- Provide hands on support and technical project management in the development, execution, and maintenance of the Process Validation program, with support from the Manufacturing, Quality Control, Quality Assurance, , and Discovery Research departments.
- Required to execute Process Validation deliverables, such as authoring of analyses and reports.
- May be required to perform other duties as assigned or as needed (eg vendor qualification, quality control, process development).
Experience with IOPQs, Batch Records, Validation Protocols, OOSIs, Technical Specification Writing for Equipment & Processes, Packaging, Labeling. Familiarity with cGMPs, regulatory filings, and compliance for sterile injectable products manufactured by aseptic processing is desired.
Education, Experience and Certifications:
- Bachelor of Science or Master of Science degree in a science, quality, logistics, analytical field (Engineering, Physics, Computer Science, Biology, Microbiology, Biotechnology)
- 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.