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!

Job Responsibilities

  • 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.

 

Position Requirements

  • 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.

About us

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.

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