Associate Director, Product Quality Assurance

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 with integrated gene editing, delivery and 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 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: The Associate Director of Product Quality for Cell and Gene Therapy Programs will act as a leader in the Quality organization and will support the quality aspects of Beam’s programs over the holistic product lifecycle. This position acts as a Quality Leader by supporting Product Quality Leads (PQLs) on program and CMC-focused deliverables and is a strategic partner with CMC functional areas across the product lifecycle. This position will have a direct impact on the product quality strategy and overall lifecycle management aspects, from an end-to-end quality perspective (development to post-commercialization). Working closely with the assigned PQLs, the role supports consistency and quality of content and product strategy across the CMC spectrum including review of CMC technical content provided for global clinical and commercial regulatory submissions as well as associated quality records. Responsibilities: Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments. Drives and takes action on Phase Appropriate Quality strategy for Beam’s products. Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation. Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc. Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.) Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL. Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives. Support clinical to commercial analytical control strategy. Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.). Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations. Authors annual product quality reviews. Responds to compliance & quality related troubleshooting activities. Supports expiry extensions in collaboration with QC. Assists in the implementation of quality systems and procedures/SOPs as needed. Enables alignment of product transition from clinical to commercial phase and tech transfers between sites. Proposes product improvement activities related to overall quality and compliance strategy. Quality reviewer for select CMC technical content provided for global clinical and commercial regulatory submissions. Support due diligence audits, site selection, and qualification of external partners as necessary. Supports other members of the Qualit