Beam Therapeutics Inc.
Associate Director, LNP Development
Beam Therapeutics Inc., Cambridge, Massachusetts, us, 02140
Company Overview:
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
Beam is seeking an Associate Director with expertise in late-stage product development. In this role, the individual will work closely with the Analytical, Technical Operations and Manufacturing groups to advance our 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 late-stage product development and guiding programs to commercialization.
We are looking for an ambitious candidate who wants to grow within the LNP development (process and formulation) group. This candidate will help shape the LNP platform and would grow with the aspirations of the organization as we advance multiple programs into later stages of development.
Responsibilities: Contributes to the Chemistry, Manufacturing and Controls (CMC) strategy. Engages in scientific and technical discussions with multi-disciplinary team members to move programs into late-stage development. Uses knowledge and expertise of statistics to collaborate on Drug Product Development: Quality by Design, formulation development and optimization, process design and optimization, scale-up, determining manufacturing design spaces, validation, experimental and registrational stability studies, probabilistic assessment of risk for critical quality attributes. Acts as a technical point of contact, or SME within the group as well as other departments; trains others. 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. Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and product development activities. As part of support for GMP manufacturing activities, assists with relevant investigations and CAPAs. Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines. Authors and supports preparation of regulatory documents. Qualifications:
PhD or MS in Pharmaceutical Sciences, Chemical engineering, Bioengineering or related field with of drug product and CMC development experience (PhD or MS with 12+ years of relevant experience). Deep understanding of late-stage product development activities. Experience with PPQ and late-stage robustness activities is preferred. Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Strong knowledge of regulatory requirements. Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration, and accountability are valued. An ideal 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 travel and support workstreams in the US and internationally. Ability to work in a hybrid environment with sufficient on-site presence.
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
Beam is seeking an Associate Director with expertise in late-stage product development. In this role, the individual will work closely with the Analytical, Technical Operations and Manufacturing groups to advance our 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 late-stage product development and guiding programs to commercialization.
We are looking for an ambitious candidate who wants to grow within the LNP development (process and formulation) group. This candidate will help shape the LNP platform and would grow with the aspirations of the organization as we advance multiple programs into later stages of development.
Responsibilities: Contributes to the Chemistry, Manufacturing and Controls (CMC) strategy. Engages in scientific and technical discussions with multi-disciplinary team members to move programs into late-stage development. Uses knowledge and expertise of statistics to collaborate on Drug Product Development: Quality by Design, formulation development and optimization, process design and optimization, scale-up, determining manufacturing design spaces, validation, experimental and registrational stability studies, probabilistic assessment of risk for critical quality attributes. Acts as a technical point of contact, or SME within the group as well as other departments; trains others. 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. Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and product development activities. As part of support for GMP manufacturing activities, assists with relevant investigations and CAPAs. Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines. Authors and supports preparation of regulatory documents. Qualifications:
PhD or MS in Pharmaceutical Sciences, Chemical engineering, Bioengineering or related field with of drug product and CMC development experience (PhD or MS with 12+ years of relevant experience). Deep understanding of late-stage product development activities. Experience with PPQ and late-stage robustness activities is preferred. Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Strong knowledge of regulatory requirements. Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration, and accountability are valued. An ideal 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 travel and support workstreams in the US and internationally. Ability to work in a hybrid environment with sufficient on-site presence.