Ours is to create a world where safe and effective regenerative medicines are rapidly developed and are widely available on a global scale, to benefit the lives of patients in need.
RoosterBio designs, manufactures, and distributes products enabling the development and commercialization of products derived from Mesenchymal Stem/Stromal Cells (MSC’s). We believe that the dawn of a new day is upon us in the fields of regenerative medicine and stem cell technologies. RoosterBio is a revenue stage company on a high growth trajectory. Our employees are driven by high impact work and are passionate about delivering the best stem cell products possible to our customers. We do not compromise on quality, innovation, or product performance. We believe in hiring and developing the best talent available within the industry. The pace is fast, the work is stimulating, and ultimate performance is expected out of each team member. Working at RoosterBio is not for everyone. It is essential to have genuine passion and commitment for the commercial translation of stem cell and tissue engineered products, as well as an appreciation of a small company environment. It is our belief that these characteristics are necessary to attain personal fulfillment and success at RoosterBio. The development of a positive, collaborative, solution focused, and high performing culture is of the utmost importance to the RoosterBio team.
We are looking for friendly, well organized, and self-driven individual to lead and develop an established QC team, while optimizing our Quality Control systems and Operations. This is a senior level role at RoosterBio that requires both strategic thinking and tactical execution. As a leader within the Operations team, the incumbent is responsible for building and managing a high-performing QC organization to ensure the quality and performance of the products we offer our customers across the globe. All these accountabilities are central to our customers having a great experience with our Company and our products. We are looking for someone with a strong work ethic, excellent communication skills, and an eye for detail that can take on more responsibilities as RoosterBio grows.
• Build and lead a high-performing team of QC scientists performing assays for product release and product stability evaluation.
• Oversee method transfer from Development; establish and qualify new QC test methods and prepare corresponding method reports.
• Oversee interactions with contract test labs, including coordination of sample submission, review, and approval of test results.
• Apply industry best practices to drive improvement of existing test methods and associated systems for data collection and documentation.
• Leads OOS/aberrant investigations including writing/approving deviation/investigation reports and initiates/executes corrective/preventive actions.
• Support the growth and development of Department capabilities to address future needs (i.e., raw material testing, method validation, establishment of in-house GMP testing)
• Direct management of personnel including training, mentoring, performance appraisals, promotions, staff hiring, and other personnel related activities.
• Team player that projects a positive, proactive, and collaborative attitude that can be a role model as the company grows.
• Experience in establishing and leading a Quality Control Team comprised of varying levels of technical expertise.
• BS/MS/Ph.D. degree in a relevant scientific discipline with 7+ years of applicable industry or academic experience.
• Strong understanding of relevant Regulatory Guidelines for testing of biologics, and the requirements for phase appropriate qualification and validation of test methods.
• Experience in a GMP-compliant QC lab setting is strongly preferred.
• Knowledge and experience with cell-based assays is essential.
• Experience in statistical data analysis and development of specifications is very beneficial.
• Excellent time management skills and the ability to work on multiple projects simultaneously are essential.
• Candidate must be eligible to work in the U.S for other than practical training.