Principal Engineer, LNP Drug Product Process Development
HQ- Cambridge, MA /
CMC & Quality /
We are seeking a highly motivated and innovative candidate with expertise in lipid nanoparticle (LNP) formulation process development and production to join our dynamic, rapidly growing, and highly collaborative team at Arbor Biosciences. Reporting to the Senior Director, CMC Tech Ops, this individual will be a technical leader in the area of lipid nanoparticle process development and characterization. This individual will play a key role helping advance Arbor’s gene editing technology in the LNP delivery platform. The ideal candidate will be proactive, enthusiastic, collaborative, and demonstrate good communication, with a desire to innovate by solving current challenges in LNP development and manufacturing.
- Lead development of LNP formulation using Quality-by-Design (QbD) principles for lipid nanoparticles (or other lipid/polymer-based delivery vehicles) to meet phase appropriate requirements to support Arbor’s goals.
- Contribute to process definition, CDMO selection, and facility fit assessment
- Provide guidance and support for tech transfer and scale up of production processes at CDMOs
- Drive fundamental improvement of LNP formation with an emphasis on formulation definition, process robustness, scale-up, and stability.
- Author and/or review process descriptions, process flow diagrams, batch documentation, SOPs, test plans, and reports in support of process scale up, tech transfer, and GMP manufacturing
- Organize workstreams and complete individual and team objectives to maintain project timelines.
- Engage cross functionally with CMC and R&D team members to ensure alignment and support for program needs
- Participate in authoring and reviewing CMC sections of regulatory filings
- Provide expertise in process engineering, design, and ongoing process improvements to support process efficiency and robustness
- PhD in Chemistry, Chemical Engineering, Biomedical Engineering or related discipline; 3+ years industry experience. Master’s degree with 5+ years of industry experience. Strong background in bioprocess development of biologics, vaccines, and/or gene therapy.
- Demonstrated ability to learn and apply new engineering disciplines
- History of working independently and managing multiple projects in a fast-paced environment
- Strong attention to detail, a good problem solver, and results-oriented
- Strong interpersonal and collaboration skills
- Experience with manufacture of LNP-encapsulated nucleic acid payloads at multiple scales (PD and GMP)
- Understanding of analytical methods required for development and characterization of LNPs and oligonucleotides
- Familiarity with statistical design of experiments (DoE) and analysis, and quality by design frameworks desired
- Detailed knowledge of cGMPs and good documentation practices as they relate to large biomolecule production, formulation, and/or purification
- Experience in authoring and reviewing regulatory documents and preparing CMC sections
- Experience with formulation development for biomolecules
- Strong organizational skills and ability to deal with complex problem solving, flexibility to adjust to changing priorities and willingness to mentor junior scientists.
- Strong collaborator with cross-functional teams and external partners
Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!
· Purposeful Action: Start with The Why
· Bold Resilience: Adopt a Growth Mindset
· Humble Authenticity: Start in the Heart
At Arbor, we are discovering, developing and making available to all patients the next-generation of genetic medicines. We are disrupting the field through our proprietary discovery engine to develop a portfolio of differentiated genetic editing and delivery capabilities. We have an unencumbered portfolio of multiple CRISPR based genetic modifiers that can be tailored to correct the underlying pathology of each genetic disease. Our pipeline of genetic medicines will focus on bringing cures to all patients with genetic disease.
We seek highly-motivated individuals with the dedication, integrity, and creative spirit needed to thrive in an innovative company. Working at Arbor offers a unique opportunity that combines the fast pace and growth opportunities of a startup with the intellectual rigor and creativity of academia. Our salaries are competitive, our benefits are generous, and our team is exceptional.
We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.