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 hands-on Manufacturing Engineer with experience in Medical Device consumable manufacturing and a passion for shepherding new products to market.
Job Responsibilities
- Oversee and manage design transfer and process transfer activities for a consumable product manufacturing.
- Optimize line layout, install new equipment, write IQ/OQ/PQ equipment protocols and assist and or oversee the execution and documentation of those protocols.
- Improve manufacturing processes by matching process output to product requirements and testing requirements to reduce cycle time and improve yield.
- Ensure test methods appropriately demonstrate product quality requirements.
- Improve existing Work Instructions. Train technicians to Work Instructions.
- Improve manufacturing efficiency and reduce cost by analyzing and planning workflow, space requirements, and equipment layout.
- Implement process metrics and track and report on metrics to monitor health of the manufacturing line.
- 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.) in Engineering or related discipline.
- Experience with Design Transfer to Manufacturing and New Product Introduction.
- Experience with Design for Manufacturability.
- Experience working closely with contract manufacturing partners and vendors.
- Experience with Scale up of consumable manufacturing in a GMP and ISO13485 environment.
- Strong analytical and problem-solving skills.
- Hands-on and able to set up processes and troubleshoot independently.
- Ability to manage different priorities and plan experiments around various constraints.
- Self-starter, ability to work without supervision.
- Excellent verbal and written communication skills.
- Computer skills such as setup of equipment software, standard Office programs such as Word, Excel, PowerPoint.
Experience
- 7+ years work experience with fabrication and manufacturing of consumables in a regulated environment.
- Experience with CAD software such as Solidworks
- Experience with laser welding of plastic components and assembly of micro-fluidic consumables a plus.
Location: Carlsbad, 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.
