About Curate Biosciences
Curate Biosciences is developing and commercializing a uniquely powerful cell processing platform that is set to transform the manufacturing of novel cancer immunotherapy products. Our Curate® Cell Processing System enables cell separation with virtually no cell loss and is poised to radically improve patient outcomes and the economic landscape of cell therapy. Designed with both manufacturing and clinical potential at the forefront, the Curate System enables production of CAR-T and other cell therapies beyond today’s limitations.
Our best-in-class solution delivers superior quality starting material that also enables significant process and cost improvements. As a result, we are positioned for a rapid growth trajectory and have a highly energized and accomplished team.
Curate Biosciences has strong venture financing from Amgen Ventures, Vensana Capital, and other major healthcare investors and is advancing application of its DCS technology to target additional cell types, disease states, and workflows.
We are seeking a Sr. Quality Engineer with a minimum of 8 years’ experience in a regulated industry and a passion for shepherding new products to market.
Job Responsibilities
- Oversee and manage design transfer and process transfer activities for a consumable product produced at a Contract Manufacturer (CMO) site in Brea, CA.
- Provide engineering support and lead troubleshooting activities on the production line. Perform systematic and documented Root Cause Analyses for failures and implement Corrective Actions.
- Perform analysis to understand and improve processes, reduce failures, and improve yields.
- Participate in design reviews and pre-validation assessments of new products and processes, and ensure the process has adequate and appropriate process controls.
- Work with Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulatory agencies
- Ensure that all equipment, instrumentation, and software is maintained in a validated state. Ensure compliance with current regulatory requirements.
- Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents
- Participate in and author sampling plan development and data analysis for design verification, new/existing product test methods and incoming inspection; ensure predetermined requirements are met
- Communicate results effectively, guiding the team through data and observations on critical process decisions.
- Coordinate with cross-functional project teams to ensure timelines are met and assist the team to balance costs, timeline, and performance.
Qualifications
- Bachelor’s degree (B.S.) or Masters degree (M.S.), preferably in a scientific discipline or life sciences
- Strong analytical, planning, and organizational skills
- Technical and administrative abilities required to carry out routine job requirements.
- Excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management.
- Ability to communicate ideas and knowledge effectively and clearly to other individuals and teams.
- Excellent problem-solving skills
- Self-starter with ability to work independently under pressure and react quickly to changing priorities
- Mentor team members in qualification/validation technical aspects, and compliance requirements
Experience
- Eight (8) years minimum direct applicable experience, with relevant experience in medical devices regulated environment
- Working experience in medical device industry with knowledge of FDA’s guidance documents and regulations, ISO and ASTM standards related to quality and medical device and IVDs
- Thorough understanding of industry regulations: cGMP, ISO QM Standards (21CFR820, ISO13485)
- Knowledge of design control principles
- Thorough understanding of Statistical Methods for Quality Assurance
Location: Carlsbad, CA or Brea, CA
If you’ve got the experience we’re seeking and are ready to play a pivotal role in a motivated and
collaborative team to commercialize transformative technology, we’d like to hear from you.
Please send your CV to [email protected]
Curate Biosciences’ policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, religion, creed, gender, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
