Join our generation.

Associate Director/Director, QC-Method Development

Cambridge, Massachusetts, United States

Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including titration to effect and the ability to re-dose. Our unique GeneWave technology allows us to overcome the limitations of existing and emerging approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time. Our vision is to make our therapies available at or near birth in order to maximize their lifetime impact, allowing people to live full lives unaffected by genetic disease.

We are a community of creative problem-solvers and independent thinkers. We are guided by strong personal integrity, humility, and energized by the collaborative, learning mindset required to create solutions for patients and their families.

Generation Bio was founded and launched by Atlas Venture, and is headquartered in Cambridge, Mass. For more information, please visit www.generationbio.com or follow @lifetimegenetx.

SUMMARY:

Generation Bio seeks an energetic and highly motivated Associate Director/ Director to guide Quality Control, method qualification and validation activities for vendor-performed and internal assays. The successful candidate will work closely with scientists in the Analytical Development team to understand the strengths and weaknesses of methods in development, transfer methods, design a strategy for qualification and validation of appropriate methods, and work with outside vendors and the team to perform qualifications and validations.

RESPONSIBILITIES:

  • Directing assay qualification and validation activities across a wide range of physical and biological assays performed in the Analytical Development group
  • Developing assay transfer protocols and guiding assay transfers as appropriate both internally and externally
  • Being responsible for the compliance of these efforts with Generation Bio and regulatory standards for method qualification and validation
  • Supervising efforts of external vendors on method qualification and validation
  • Communicating analytical approaches and results to senior management in the Research and Development groups
  • Partnering with peer groups within Upstream and Downstream Process Development as well as Drug Product to build CMC strategies for our clinical candidates.

Requirements

  • Ph.D. in Analytical Chemistry, Biochemistry, or equivalent
  • Minimum of 5-8 years relevant experience.
  • Demonstrated proficiency in evaluating a broad spectrum of analytical methods
  • Experience in regulated environments (e.g. Quality Control) highly desired, with experience in a GMP setting helpful
  • Previous experience qualifying methods for regulatory submissions is required, and experience with validating methods is highly desired
  • Ability to achieve consensus across internal stakeholders in Development, Quality, and Research.
  • Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged
  • Ability to diversify technical skillsets in a fast-paced organization
  • Ability to work with others to troubleshoot complex technical and scientific problems while showing sufficient independence in execution and thought processes

POSITION: Full-Time, Exempt

EEOC Statement: Generation Bio believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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