Drug Manufacturing 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 schedule, train, and perform aseptic filling, labeling and packaging duties. The candidate will be familiar with and work within all regulatory requirements of a cGMP environment related to aseptic 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 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 equipment and instruments is an advantage.
Essential Duties and Responsibilities:
- Prepare, review, and maintain standard operating procedures, protocols, batch records, and other forms of good documentation for bioprocessing and packaging functions in a cGMP setting that is regulated by the FDA
- Develop solutions to equipment and process technical problems during aseptic manufacturing, filling, and labeling.
- Perform 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. Troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process/changes and improvements may be needed in this bioprocessing
- Participate in cross-functional teams to drive alignment and manufacturing efficiency
- Operate in a clean room setting, and perform aseptic gowning for ISO 5 areas
- Perform viable and non-viable environmental monitoring
- Operate various bioprocessing equipment
- Interact with Quality Assurance and Quality Control to solve any quality issues that may arise
- Assist others when needed
Experience with labeling for regulatory agencies and packaging of final drug products is preferred. Familiarity of cGMPs, regulatory filings, and compliance for sterile injectable products manufactured by aseptic processing is a must.
Education, Experience and Certifications:
- Bachelor of Science or Master of Science degree in a science field (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.