Be Biopharma is looking to hire highly motivated, experienced, and innovative thinkers to join our growing team of passionate researchers to leverage B cells as a novel class of cellular medicine. This is an exciting opportunity to be part of a foundational team and help build Be Bio!
- Identify, test, develop, qualify and implement technologies required to support viral vector manufacturing
- Provide technical and oversight experience towards the buildout and startup of manufacturing operations, including CRO and/or equipment selection, SOPs, batch records, risk assessments, and material ordering/management
- Plan and execute experimental work to develop and optimize upstream unit operations for viral vector production
- Oversee the development, optimization, and qualification/validation of robust molecular assays for analytical work of Be Bio cellular products:
- NGS, qPCR, ddPCR and other molecular assay platforms for the characterization of cell and gene therapy drug products, vector, and critical starting material
- Evaluation of nucleic acid characteristics like residual impurity DNA, residual AAV and sgRNA
- Gene editing features like on- and off-target editing, etc.
- sgRNA sequencing
- Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
- Represent the analytical development & vector functionality in cross-functional management meetings, and actively participate in strategy design, execution, data presentation and follow-up.
- Collaborate with external partners, CMOs to lead or monitor outsourcing activities, manage timelines, and ensure deliverables.
- Author technical reports, protocols, and analytical sections of regulatory filings.
- PhD in Life Sciences, bio-engineering, or related discipline with a minimum of 15 years relevant experience
- Prior experience working with viral vector design, manufacturing, and qualification technologies
- Familiarity with analytical methods using techniques like next-generation sequencing (NGS) platforms, Sanger sequencing, qPCR, droplet digital PCR (ddPCR)
- Next-generation sequencing (NGS) experience and proficiency with various molecular biology and sequence analysis software is required
- Past work experience with gene therapy product development (AAV vectors) is preferred
- Strong knowledge of CRISPR gene editing, and analytical methods for cell and gene therapy products is required
- Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate GMP requirements is required.
- Prior experience of IND, BLA or equivalent regulatory filings is highly preferred.
- Experiences with analytical or statistical software (e.g., JMP, Softmax Pro, Gen5 etc.), is highly desirable.
Be Biopharma is developing a proprietary class of engineered B cell medicines to unleash the power of cell therapies beyond cell-cell contact-dependent killing (e.g., CAR-T cells). As the centerpiece of the body’s non-contact dependent humoral immune system, B cells offer a platform for cell therapy that can secrete large amounts of diverse molecular cargo in a physiologically-regulated manner. Based on discoveries by David Rawlings, MD (Chief of Immunology, Seattle Children’s and U Washington) and Richard James, PhD (Assoc Prof of Pediatrics, Seattle Children’s and U Washington), Be Biopharma is developing a pipeline of engineered B cell medicines that can restore lost signaling, regulate disease-causing pathways, and promote defense. The company will aim to demonstrate rapid proof-of-concept in genetically-defined monogenic disease, in parallel expanding to a broader set of applications across immune disease and oncology. Be Biopharma was founded in 2020 and is supported by a syndicate of leading biotech investors.