Scientist, Analytical Development

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Scientist, Analytical Development

Waltham, Massachusetts

|

Direct (Permanent) Full Time

|

NA

Waltham, Massachusetts

Direct (Permanent) Full Time

NA

September 07, 2022

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Job ID: P1305352BOSSCM_1662565771

September 07, 2022

Job ID: P1305352BOSSCM_1662565771

Job Summary

Job Id: P1305352BOSSCM_1662565771 Apply Now

Scientist, Analytical Development, Gene Therapy:

Our client is 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 the company 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 their 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 the company 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.
P1305352BOSSCM_1662565771

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™