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Senior Scientist, Analytical Development Cell Therapy

Employer
Resilience
Location
La Jolla, CA
Start date
Sep 28, 2022
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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 Analytical Development group in the Cell Therapy Franchise. This role will focus on cellular analytical development and product characterization.

This scientist will:

  • Help establish Resilience as a leader in cell therapy analytical science through the application of processes, procedures and technologies in the development of best-in-class testing strategies

  • Identify and explore state of the art technology platforms and disruptive approaches to existing assay platforms

  • Collaborate with analytical groups in other Resilience Franchises to develop best practices and to further enhance a center of analytical excellence within the company

Job Responsibilities

  • Develop and optimize program-specific assays to quantify cell product potency using biochemical and cell-based assays

  • Function as CMC-Analytical lead on program teams and interact with external stakeholders on tech transfer activities, assist in troubleshooting method issues and support validation/qualification campaigns

  • Maintain and enhance current knowledge of emerging technologies in bio-analytics to support improvements for existing analytical strategies and represent Resilience at external events as subject matter expert through presentations and active participation

  • Author and review SOPs, reports and other technical documents and regulatory submissions

  • Analyze data with available tools, interpret results, and present the data to internal and external stakeholders

Qualifications

  • Master's degree or PhD in molecular/cellular biology, cell physiology, biochemistry or related field

  • Minimum 5 (with a PhD) or 7 years (with a Master's) of relevant analytical development experience in an industry setting

  • In-practice knowledge of the ICH and USP guidelines for assay qualification and validation

  • Demonstrated ability to efficiently develop an assay from concept to a qualified/pre-validated state

  • Experience using cell imaging, flow cytometry, Luminex, molecular, cell biology, and enzymatic methods

  • Experience developing bioanalytical assays for cell and gene therapy products

  • Extensive experience with experimental design, data analysis organization, and presentation of complex scientific data, integrating this into a validation workflow

  • 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 IND authoring

  • Experience in cell-based potency assays, cell banking and cell line characterization

  • Experience in CMC-Development setting

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

  • Experience with analytical or statistical software, e. g., Softmax Pro, Graphpad Prism, JMP, XLfit, etc.

  • Knowledge of and interest in laboratory and equipment automation

#LI-LE1

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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