Principal Scientist, Analytical Development (Gene Therapy)

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Principal Scientist, Analytical Development (Gene Therapy)

Waltham, Massachusetts

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Direct (Permanent) Full Time

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NA

Waltham, Massachusetts

Direct (Permanent) Full Time

NA

September 01, 2022

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Job ID: P1305355BOSJB_1662041283

September 01, 2022

Job ID: P1305355BOSJB_1662041283

Job Summary

Job Id: P1305355BOSJB_1662041283 Apply Now

Principal Scientist - Cellular and Molecular Biology Analytical Development, Gene Therapy

Our Client is building a robust, dynamic, and diverse network of manufacturing capabilities and collaborations - investing in innovation every step of the way. We are looking for a highly motivated Principal Scientist to contribute to the gene therapy analytical development group based out of Waltham, MA. The qualified candidate will:

  • Help establish Resilience as a leader in gene therapy analytical science through the application of processes, procedures, and technologies in the development of best-in-class analytical testing strategies
  • Identify and explore state of the art technology platforms and disruptive approaches to improve existing ways of measuring critical quality attributes for viral vector products
  • Collaborate with analytical groups in other Resilience franchises to develop best practices and to function as a center of analytical excellence within the company

Title commensurate with relevant experience, depending on candidate background. This role will focus on either cell and molecular analytical development or biophysical characterization.

Job Responsibilities

  • Incumbent will lead, mentor and develop a team of associate scientists
  • Initiate, direct, execute the development and optimization of new and improved Analytical Assays driving AAV-structure-function understanding to support the gene therapy franchise
  • Function as CMC-Analytical lead on program teams and interact with internal and external stakeholders on Tech Transfer activities, assist in troubleshooting method issues and support qualification campaigns
  • Maintain and enhance current knowledge of emerging technologies in bio-analytics, with a focus on molecular assays, to improve 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 bioinformatic tools, scientifically sound interpretation and present the data to internal and external stakeholders.

Qualifications

  • PhD or master's degree in molecular / cellular Biology or functionally related field
  • Senior Scientist: 5+ years (PhD) or 10+ years (MS) of relevant analytical development experience
  • Principal Scientist: 8+ years (PhD) or 13+ years (MS) of relevant analytical development experience
  • Extensive hands-on expertise in Molecular cell biology and biochemistry-based method development for digital PCR (ddPCR or dPCR), next-generation sequencing (NGS), quantitative (RT-qPCR)
  • 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 state and strong hands-on experimental design, data analysis, and presentation skills
  • Self-starter and team player, with demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment
  • Ability to communicate and operate effectively within cross-functional teams
  • Proven ability to manage and develop a team of direct reports

Preferred Qualifications

  • CMC-Analytical CMC-Lead experience
  • Experience in developing methods and performing the analysis of AAV, LVV or gammaRV or similar viral vectors used in Gene Therapy
  • Experience with Bioinformatics in a CMC-Development setting
  • Experience with analytical or statistical software, e.g. JMP, Softmax Pro, XLfit, Gen5, etc.
  • Knowledge and interest in laboratory and equipment automation

P1305355BOSJB_1662041283

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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.

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