Resilience is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients lives.
As the Single-Use Technology Lead, you will be responsible for designing and implementing a single-use technology (SUT) strategy for managing process consumables developed and used throughout the site. This encompasses work processes that originate with the identification of new SUT process needs and includes the design, enrollment, and management of the process consumables used on site and across the Resilience network. You will work cross-functionally with site operations teams and external partners to develop SUT designs and a consumables bill of materials for new site projects. You see opportunities in challenges, a path forward where it has never been tried before, and seek to consistently ask of technology, "what s a better way" to execute modern biomanufacturing operations.
Design, specify, and lead the implementation of SUT solutions across the site.
Provide technical expertise and support to Manufacturing, Engineering, and other departments during the design and operation of new process systems.
Develop engineering lifecycle documentation, such as system user requirements, and translate process requirements into single-use component specifications and design schematics.
Lead cross-functional project teams during SUT equipment enrollment, material qualification activities, and E&L studies.
Support technology transfer and process development activities on site as an engineering lead and SUT subject matter expert. This includes assessing new and existing SUT solutions required to meet client process needs.
Collaborate with the Resilience global teams, other sites, and the Resilience SUT community of practice on Company SUT strategy and standardization.
Promote and ensure compliance with all safety and quality regulations.
12+ years of relevant work experience in operations/manufacturing environment with demonstrated technical expertise in single-use technology design and implementation.
Bachelor of Science degree in an Engineering or related discipline. Preferred area of study: Chemical, Biomedical/Bio, or Mechanical Engineering.
Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) and working knowledge of pharmaceutical/biotech processes and associated utility systems.
Strong analytical skills for troubleshooting and root cause analysis
Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross functional projects
Fluid collaboration skills with internal partners and external vendors/suppliers.