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Position Overview:

Beam is seeking a principal scientist with expertise in nanoparticle process and formulation development. In this role, the individual will work closely with the Discovery, Technical Development, Manufacturing and Analytical groups to advance our early pipeline into development. The candidate will work on formulation and scale up of lipid nanoparticles (LNPs) targeting different organs and cell types. They will work as part of a team to develop drug products with the goal of bringing in vivo base editing to patients. An ideal candidate would have good understanding of drug product process development and nanoparticle formulation.

We are looking for an ambitious candidate who wants to grow within in the process and formulation development group. This candidate will help shape the LNP platform and would grow with the aspirations of the organization as we advance into later stages of development.

Primary Responsibilities

• Uses knowledge and expertise of statistics to collaborate with scientists in application of statistics to Drug Product Development: Quality by Design, formulation development and optimization, process design and optimization, experimental manufacturing campaigns, determining manufacturing design spaces, validation, experimental and registrational stability studies, probabilistic assessment of risk for critical quality attributes.
• Design and execute experiments to enable a robust formulation and reproducible process for manufacture of clinical trial materials.
• Contributes to the Chemistry, Manufacturing and Controls (CMC) strategy. Engages in scientific and technical discussions with multi-disciplinary team members to move forward with speed and accountability.
• Leads technology transfer projects, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
• Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines.
• Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and product development activities.

Qualifications

• PhD in Pharmaceutical Sciences, Chemical engineering, Bioengineering or related field with of drug product and CMC development experience with 5+ years industry or related experience or MS with 18+ years industry or related experience.
• Deep understanding of lipid nanoparticle formulation for gene therapy products. Product development experience especially in nucleic acids and drug delivery is preferred.
• Comprehensive knowledge and understanding of solubility, phase-separation, colloidal stability, electrostatic and hydrophobic interactions; at a level that enables hypothesizing options for rational design/selection of excipients and formulation conditions (e.g. pH, ionic strength) to achieve directed self-assembly in complex mixtures.
• Familiarity with ultrafiltration and aseptic unit operations for sterile drug product manufacture.
• Experience using statistical computer languages (R, Python, SLQ, etc.) to manipulate data and draw insights from large data sets. Knowledge of statistical techniques and concepts (regression, properties of distributions, statistical tests, and proper usage, etc.)
• A successful candidate will have excellent computational, written, and verbal communication skills, strong organizational abilities, and an ability to work with a diverse group of scientists and engineers.
• Ability to adapt to increasing scope and complexity of work brought on by growth/change and helps others manage through change.