Reporting to the Senior Director, Manufacturing Operations, this process development role will focus on optimizing, developing, and establishing procedures for AVROBIO’s manufacturing platforms. This is a hands-on, lab-based role. The work is oriented around cell culture techniques and general molecular biology for the purpose of drug development for rare disease using gene therapy. You will be responsible for working cross-functionally with Research and Development.
- Advance and develop analytics of gene delivery processes.
- Perform characterization, qualification, and validation for processing of drug substances and drug products.
- Work with Contact Manufacturing Organizations (CMOs) and vendors to support platforms.
- Support scale-up and operations for GMP production of recombinant plasmids, vectors, and cell products.
- Assist in validation of production and purification of vector-based products.
- Assist in writing and review of protocols and technical reports.
- Sc. with 6+ years or M.S. with 4+ years, or Ph.D. with 2+ years of experience in Microbiology, Molecular Biology, Biochemistry, Biochemical Engineering or a related scientific degree.
- Proficient in general molecular biology techniques.
- Demonstrated ability to work independently while designing and executing scientific studies with technical excellence and relevant results.
- Manufacturing and tech transfer/scale-up experience is preferred.
- Previous experience with technology development for the manipulation and selection of bacterial cell lines, including familiarity with bacterial cell line transformation and screening for productivity required.
- Experience with bioreactor fermentations and culture optimization, including batch, fed-batch and/or inducible fed-batch bioreactor technology.
- Previous work in gene therapy, vaccines, or biological methodology is a plus.
- Experience working with bacteria for generation of recombinant proteins and plasmids.
- Experience with eukaryotic cell culture and transfection development.
- Ability to troubleshoot complex technical and scientific problems required.
- In-depth knowledge of aseptic processing.
- Ability to prepare technical documents for internal distribution or inclusion in regulatory filings.
- Ability to present data and actively participate in departmental meetings or cross-functional area project teams in a fast-paced environment.
- Excellent oral and written communication skills.
To apply, email your resume to: email@example.com
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.