Director/Senior Director CMC Analytical Validation

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Job Summary

The Director/Senior Director CMC Analytical Validation is responsible for method transfers; method improvement; method remediation and method validation/verification and/or troubleshooting for late stage clinical products within the Quality Control laboratories. S/he manages both external CMOs and CROs in the cell and gene therapy space, including but not limited to, Drug Product (DP) release testing and characterization. In cooperation CMOs and CROs, S/he is responsible for planning, reviewing and approving analytical method qualifications and validation preBLA at all CMOs and CROs. S/he will be highly interactive and function at a high level in a matrix management environment that includes, but may not be limited to, Analytical Development, Process Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Discovery Research. The Director/Senior Director CMC Analytical Validation ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Key Responsibilities
  • Monitors and manages the life cycle of assigned analytical methods supporting late stage clinical products. This includes, but not limited to, oversight of stability programs, reference standards and preBLA commitments.
  • Designs and oversees experiments evaluating analytical methods associated with commercial products for feasibility, method improvement, remediation, and/or troubleshooting.
  • Leads continuous cGMP analytical improvement projects. This includes, but may not be limited to, constant state of validation, improvement of methods and sustaining compliance with global requirements.
  • Troubleshoots method and/or equipment issues to the root cause. Assesses issues with resource management and failure investigation review
  • Resolves non-routine laboratory issues and problems expeditiously.
  • Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
  • Acts as project lead for assigned programs
Minimum Requirements/ Qualifications
  • PhD in molecular biology, virology, biochemistry or related field and a minimum of 7 years of progressively responsible experience in cell and gene therapy Quality Control, MS&T or AS&T roles OR a Master’s degree in these same disciplines and a minimum of 9 years of relevant and progressively responsible experience in these same areas.
  • Comprehensive experience with the analytical methods used for cell and gene therapy in-process testing, release testing and characterization, with an emphasis on potency assays.
  • Expert level knowledge of CMC analytical and regulatory requirements.
  • Significant and applied experience in laboratory operations, including development and adherence to quality metric programs
  • Experience in departmental budgeting, capex procurement, IQ/OQ, safety, and status reporting to Senior Management.
  • Expert level knowledge of cGMP requirements as they pertain to analytical development and quality control testing.
  • Functional knowledge of mammalian cell culture.
  • Expert knowledge of cell-based assays, flow cytometry, qPCR, ddPCR, ELISA and molecular biology techniques.
  • Prior experience the commercial release testing within CROs/CMOs.
  • Team oriented and able to manage multiple projects across various development stages.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer