MULTIPLE POSITIONS AVAILABLE @ XCELLBIO

Xcell Bio is a venture-backed biotech startup located in Mission Bay, San Francisco. Our mission is to develop transformative cell culturing instruments and predictive assays for cell and gene therapies. Xcellbio is recruiting talented and creative scientific researchers to join the R&D group. We are looking for individuals with strong communication skills and technical expertise in stem cell biology and/or immunology. Candidates with 3+ years of primary cell culturing experience (human or mouse) is required for this role. Competitive salaries, comprehensive benefits package, and company stock options will be offered to successful applicants. Xcell Biosciences is an Illumina Accelerator company, a member of the Bayer CoLaborator, a BayBio FAST awardee, a OneStart Business Competition 2014 Finalist, QB3 nominated company in the “Most Intriguing Company” category for 2015, Top 15 Most Promising Biotech Startups in 2018 by StartUp City, as a top 5 most promising biotech companies in Mission Bay in 2019 by the San Francisco Business Times, and has been featured in publications such as GEN, GenomeWeb, Nature, and Science among others.

BRIEF DESCRIPTION OF POSITION:

We are seeking a Senior Cell Therapy Manufacturing Systems Engineer with a software and hardware background to join our product development team for cell therapy manufacturing equipment. As a Senior Systems Design Lead, you will manage various engineering aspects of development, tech transfer, and launch of a novel, industry-leading manufacturing system for personalized/autologous cell therapies. An ideal candidate will have direct experience in working on technologies for immune cell therapy production (stem cell or other human primary cell bioprocessing hardware experience, familiarity with GE Wave bioreactors, Lonza Cocoon, and/or Miltenyi Biotec CliniMACS Prodigy systems). In this role, you will engage in all facets of product development including concepting, documentation, design, prototyping and transfer to manufacturing in a complex regulatory environment. The candidate must have the drive to solve complex technical problems, work in a fast-paced environment, and across multiple stakeholders and subject matter experts.

• Lead activities in the arena of manufacturing platform development for cell immunotherapy.
• Collaborate with a diverse group of engineers, biologists, software designers, end-users and external suppliers.
• Participate in the translation of user and functional requirements to design specification, concepts and direction.
• Assist in the collection and documentation of user and functional requirements.
• Design within parameters of applicable compliance and human factors standards for ease of marketing.
• Execute project scope throughout the conception, design and pilot phases.
• Generate and review documentation required for manufacturing technical transfers.
• Support of activities pertaining to market-readiness of product, including qualification activities.

EDUCATION, EXPERIENCE, AND SKILL REQUIREMENTS:

• Degree in Chemical, Mechanical, Electrical, Computer Science, Bioprocessing or related engineering field: Bachelors with 10+ years' experience, or Masters with 8+ years' experience, or PhD with 5+ years' experience in designing integrated systems for medical or pharmaceutical industry for immunotherapy
• Sound knowledge of design, development and manufacturing transfer
• Industry experience in automation for process equipment with a proven track record for designing, implementing and supporting automation solutions for complex multidisciplinary problems
• Familiarity with FDA and EMA requirements for manufacturing equipment and software, including 21CFR part 11 and GAMP5 guidelines, and UL and EMC certifications.
• Advanced understanding of mechanical, electrical and software systems, focus on mechanical
• Strong leadership and communication skills with ability to make decisions
• Must be comfortable in a seed-stage start-up environment, and with a mix of cash and equity
• Please note if you are legally authorized to work in the United States in your application