Associate Director, Core Analytics

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Associate Director, Core Analytics

The core analytics lab will work in coordination with the Cellular Process Development team to generate analytical data from samples collected during the process optimization and process characterization experiments. Responsible for the transfer and successful implementation of all Drug Product release and characterization assays in house. He/ She will be knowledgeable in assay qualification, sample management to ensure high throughput testing and good documentation practices to ensure data integrity in late phase Process Development. This is a managerial role, leading a team of Research Associates. Responsibilities will include drafting all key documents in preparation for late-stage activities including risk assessments and reports. He/ She will participate in cross-functional activities.

Cambridge
Manufacturing
Mar 1 2021
Key Responsibilities
  • The head of a new Core Analytics unit at AVROBIO will provide testing support to Process Development for both early and late-stage activities.
  • Responsible for establishing the Core Analytics laboratory and build a team to run the unit. Analytical testing will include cell-based assays, PCR based genome scoring methods, enzyme activity or functionality assays, ELISA based assays, flow cytometry and colony-forming assays, etc.
  • Responsible for the transfer and successful implementation of all Drug Product release and characterization assays in house
  • Responsibilities will also include establishment of routine testing for drug product characterization using molecular and biological (cell) methods.
  • Qualify assays and manage/document routine testing of process development samples
  • Author and review phase-appropriate method qualification protocols and reports
  • Provide procedure driven, qualified assay support for manufacturing investigations
  • Collaborate with assay development to identify critical assays requiring improvements and provide analytical expertise for the development of cell product characterization assays, viral vector assays and early-stage product potency assays
  • Assist in the review of analytical data for characterization, release and stability including technical review of supporting documents reports and change controls.
  • Assist in the writing and review of CMC sections for regulatory submissions.
Minimum Requirements/ Qualifications
  • PhD and 4+ years of industry experience, Master’s degree and 8+ years of directly related experience, or bachelor’s degree and 12 years of directly related experience.
  • An in-depth understanding of analytical development for biologics or more specifically autologous hematopoietic stem cells (HSC) cell products and viral vectors or vaccines including methods for biophysical characterization and cell-based assays
  • Knowledgeable in assay qualification and sample management to ensure high throughput testing
  • Experienced on good documentation practices to ensure data integrity in late phase Process Development
  • Experience with assay development and assay troubleshooting
  • Experience in working with and managing outside vendors is highly desirable
  • Experience with assay validation and tech transfer to external vendors is highly desirable
  • This is a hands-on position requiring conducting laboratory experiments and the flexibility to move between the management and execution as needed
  • Understanding of requirements for development of biologics including regulatory requirements for product comparability and general knowledge of cGMP/ICH/FDA regulations.
  • Prior experience with writing CMC sections for regulatory filings is a plus
  • General knowledge of process development and manufacturing and scale-up for biologics is a plus
  • Strong organizational and project management skills with the ability to embrace change and multi-task in a fast-paced environment
  • Track record of completing deliverables within specified timelines.
  • Excellent communication, technical writing, and presentation skills
  • Independently motivated, detailed oriented and a good problem-solving ability
  • Ability to lead teams as well as work effectively in a cross-functional team.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and incorporation of multiple points of view
About AVROBIO

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