Scientist, Analytical Development, Gene Therapy

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 Scientist to contribute to the Gene Therapy Franchise (GTF) Analytical Development group with a focus on biophysical characterization methods. The qualified candidate will:

• Contribute to a state-of-the-art analytical platform to support and propel process development and final material testing for a wide variety of gene therapy products.

• Develop and apply best-in-class processes, procedures and technologies to establish Resilience as a leader in gene therapy analytical sciences.

• Collaborate with analytical groups in other franchises to test new technologies, develop best practices and further enhance Resilience's center of analytical excellence.

Job Responsibilities

• Design, develop, optimize and execute biophysical and analytical chemistry methods to characterize AAV materials. Troubleshoot problematic samples and inform process steps for small- and large-scale production processes.

• Design and develop orthogonal testing matrices to critically evaluate different assays and create robust, efficient platform assay panels for AAV materials.

• Maintain and enhance current knowledge of emerging technologies in bio-analytics and biophysical characterization to support continuous improvement of analytical strategies.

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

• Analyze data with available bioinformatic tools, scientifically-sound interpretation and present the data to internal and external stakeholders.

• Represent Resilience at external events through poster presentations, co-authorship of manuscripts, and other forms of active scientific participation.

Qualifications

• Degree in analytical chemistry, biochemistry, molecular/cellular biology or related field.

• 0-2 years (for PhD), 2-4 years (for Master's), or 5+ years (for Bachelor's) of relevant industry experience in analytical method development, process development testing, or similar. (Title/level commensurate with experience for candidates with additional industry experience.)

• Demonstrated capabilities in efficient and thorough analytical method development: ability to lead or support the development of an assay from initial concept to a qualified/pre-validated state.

• Extensive hands-on experience and familiarity with biophysical characterization techniques such as AUC, DSC, DSF, SPR/BLI (Octet), DLS/MALS, CE-SDS/CiEF/CZE, various U(H)PLC methods (SEC/RP/IEX), LC/MS-MS, and/or related techniques.

• Extensive experience with experimental design, data analysis, and the organization and presentation of complex scientific data.

• 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 developing methods and performing the analysis of AAV or similar viral vectors.

• Knowledge of the ICH and USP guidelines for assay qualification and validation.

• Experience in a CMC-development setting.

• Experience with analytical/statistical software (JMP, Softmax Pro, XLfit, Gen5).

• Knowledge of and/or interest in laboratory and equipment automation and maintenance.

• Proven ability to manage and develop a small team of direct reports.

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