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Senior Scientist, Process Development Cell Therapy

Employer
Resilience
Location
La Jolla, CA
Start date
Sep 28, 2022

View more

Discipline
Engineering, Science/R&D, Biotechnology, Biotherapeutics
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Resilience is building a robust, dynamic, and diverse network of manufacturing capabilities and collaborations – investing in innovation every step of the way. We are seeking a talented Senior Scientist to contribute to the Process Development group in the Cell Therapy Franchise. The Process Development Senior Scientist will perform studies to develop and optimize the manufacturing process of cellular therapies per product design to support client development programs.

Job Responsibilities

  • Perform development studies including creating and optimizing manufacturing platforms including modules such as cell isolation, cell culture, cell transduction and cell cryopreservation across multiple modalities (immune cells, CD34+ stem cells, iPSCs, etc.).

  • Close collaboration with analytical development on site as well as additional cell therapy sites within the franchise.

  • Collaborating with MSAT and clients to ensure manufacturing processes have an appropriate fit for the manufacturing facility.

  • Incorporate newly available technologies into the manufacturing platform and client projects

  • Evaluate raw materials and develop proper evaluation approaches to select those that are critical to the manufacturing process.

  • Function as Process Development lead on program teams and interact with external stakeholders on tech transfer activities, assist in troubleshooting and support other critical development activities.

  • Author, review and approve technical and scientific documents including but not limited to SOPs, Master Batch Records, study protocols and reports.

  • Lead/participate the Resilience contributions in the preparation of CMC documents for client regulatory filings

  • Train and mentor technical staff; may supervise scientific and technical staff, either directly or indirectly.

  • Demonstrated ability to independently design, execute, analyze and report process studies.

  • Other activities as assigned.

  • Will require some weekend and off-hours work.

Qualifications

  • BA/BS, Master's degree or PhD in Immunology, Cell Biology, or related field

  • Minimum 5 (with a PhD), 7 years (with a Master's) or 10 years (with a BA/BS) of relevant process development experience in an industry setting

  • Hands-on experience with primary cell culture and cell processing methods.

  • Experience with cell based analytical techniques and flow cytometry-based applications

  • Strong record keeping skills; excellent oral and written communication skills.

  • Familiarity with statistical software applications (e.g. Minitab, JMP)

  • Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment

  • A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment

  • Ability to communicate and operate effectively within cross-functional teams

Preferred Qualifications

  • Experience in generating IND-enabling content and IND document authoring

  • Experience in CMC-Development setting

  • Experience mentoring and/or managing junior scientists, interns, co-ops

  • Knowledge of global regulatory and guidance related to advance therapies and biologics

  • Experience with technology transfer, manufacturing process scale-up

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Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Find Us
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States
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