The Director will provide scientific, technical and strategic leadership and oversight of Bioanalytical Science deliverables and play a pivotal role in supporting AVROBIO’s preclinical projects through first in human of our cell and gene therapy drug development process.
The individual has strong scientific know-how and demonstrated expertise in the field of vector and cell based bioanalytical assay design, development, troubleshooting and qualification. He or she must have excellent interpersonal skills and will work closely with representatives from research, clinical development, manufacturing and project management groups to ensure assay timelines are aligned with corporate deliverables. He or she must be familiar with FDA guidance documents and industry white papers.
The position requires adaptability, excellent planning, organization and communication multidisciplinary skills as well as the ability to work in a fast-paced, team-oriented, environment.
- Develop and qualify biochemical methodologies, and bioassays for characterization of drug products, lentiviral vectors, plasmids, and residual impurity analysis for Avrobio’s Preclinical Studies. Examples of analytical testing include, but are not limited to, cell-based potency assays for the LVV-based gene therapy product development.
- Deep understanding of analytical testing including but not limited to qPCR, ELISA, and cell-based assay to support our lentiviral vector (LVV) platform. Collaborate closely with the method development and quality control groups to support characterization, method development, optimization, troubleshoot, transfer and validation.
- Oversight of biomarker assay translation from discovery to clinical studies assuring translatability across our drug development process.
- Provide technical leadership, expertise and mentorship to direct reports for vector and cell- based analytics, method optimization, qualification and routine testing.
- Author/review method SOPs and technical protocols/reports.
- Identify and manage external laboratories executing routine testing for characterization of cell & gene therapy vector and drug products, mRNA, and residual impurities.
- Support assay qualification and development activities and interact with CMOs and other vendors, as needed.
- Provide support during transfer of analytical methods to labs or external vendors.
- Provide support as required during method validation.
- Generate, manage, evaluate, and maintain critical data and reports in a highly organized manner with good documentation practices.
- Actively collaborate with cross-functional teams and participate in team discussions and decision-making.
- Provide subject matter expertise into the method performance review.
- Participate in generation of bioanalytical reports and sections for regulatory filings
- Evaluate and implement new bioanalytical methods and technologies to solve challenging bioanalytical issues.
- Keep current with changing FDA and EU regulatory requirements for bioanalysis.
Minimum Requirements and Qualifications:
- Ph.D in biological sciences such as Immunology, Cell Biology, Biochemistry, Virology, Molecular Biology or related fields
- Minimum of 10+ years relevant experience in biotech or pharmaceutical assay development supporting preclinical and process development teams.
- Experience in gene and cell therapy working with vector and cell-based bioanalytical assays and characterization.
- Hands-on experience with development and routine testing using cell-based assays for release and characterization including data analysis
- Experience training and supervising staff desirable.
- Strong background in mammalian cell culture, flow cytometry, qPCR/ddPCR, and ELISA.
- Use of scientific methodology to solve problems or to pursue scientific inquiry
- Pro-actively propose solutions to observed problems.
- Familiar with data analysis software, such as MS Excel, PLA, and SoftMax.
- Experience and ability to use DOE for assay optimization and robustness.
- Knowledge of relevant USP/ICH/EU regulations, GMP/GLP requirements, and industry practices.
- Excellent writing and editing skills are essential, including highly developed computer skills using Microsoft Word, Excel, PowerPoint, SoftMax Pro and Graph Pad Prism
- Experience in preparing documents for inclusion in regulatory submissions including filing of INDs, CTAs and BLAs
- Experience in developing assays that meet performance requirements using different technologies including ELISA, MSD, Gyros, FACS, PCR, etc
- Highly collaborative team player who fosters open communication and facilitates. mutual understanding and cooperation between all stakeholders.
- Excellent organizational, analytical, and communications skills.
- Track record of completing deliverables within specified timelines.
- Strong scientific writing and presentation skills.
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AVROBIO, Inc is an EEO employer
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.