Director, Control Strategy, Analytical Development

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 looking for a highly energetic and highly talented Director to join our growing Analytical Research and Development team. The incumbent will be primarily responsible for leading various workflows pertaining to product attribute detection and control. Working with the Analytical Program Lead (APL), Process and CMC leads, the incumbent will develop and document justifications for an integrated process and analytical control strategy for late-stage molecules (primarily for C>). For late stage it’s also important to possess an intimate understanding of in-process methods, formulations, degradation pathways, and be able to interpret release and characterization data. This individual will also need to work with analytical teams to ensure methods are designed appropriately to detect and control attributes within the specifications typically required for commercial use. Knowledge and/or background in IP-RPLC, CE, SEC immunological, PCR, UV, cell-based potency assays, for late-stage applications is necessary. The lead candidate should also have demonstrated leadership in a similar role at a Biotechnology or large Pharma company. The ideal candidate should have deep understanding of ICH guidelines, Quality by Design (QbD), and Critical Quality Attributes (CQA) assessment. Extensive understanding of cGMP regulations and developing risk-based analytical control strategies around Cell and Gene therapy products is necessary.

Responsibilities:

• Responsibilities for proposing an integrated process and analytical control strategy based on method, molecule, and process understanding for programs at pivotal/commercial stages of development for C>
• Capable of applying elements of QbD and ICH Q14 to assist with developing an enhanced process and analytical control strategy
• Analyze, interpret, and present data to internal and external audience using various formats
• Accountable for creating and documenting key analytical deliverables such as JoS, CQA reports, Method Performance assessments, etc.
• Evaluate and incorporate structure/function data, when possible, to support specification setting including literature searches to provide direction to the broader teams
• Possess an intimate understanding of in-process characterization data and working with process teams determine impact of process performance on specifications for drug substance and drug product
• A thought leader in Analytical Research and Development

Qualifications:

• PhD degree with 15 years’ experience or MS degree with 15 years analytical development experience in a Pharmaceutical or CDMO organization
• Previous experience with assay qualifications and validation is necessary
• Previous experience with writing CQA and JoS documents for late-stage molecules
• Good understanding of cGMP manufacturing guidelines
• Knowledge of key analytical testing of mRNA and LNPs
• Proven Leadership
• Effective communication skills
• Strong work ethic
• Clear and effective written and verbal communication skills, with excellent technical and scientific writing skills
• Able to deliver across multiple projects, prioritize demands, and thrive under tight timelines
• Strong interpersonal skills, ability to influence, and ability to work in a fast-paced and collaborative environment
• This position is an onsite role, but some level of virtual off-site work is feasible