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Beam Therapeutics · 5 days ago

Senior Director, Gene Therapy Operations (Apheresis)

Cambridge, MA

Full-time

Hybrid

Director/Executive

$260K/yr - $320K/yr

10+ years exp

Beam Therapeutics is a biotechnology company focused on precision genetic medicines. They are seeking a Senior Director for Gene Therapy Operations to lead a team responsible for patient coordination, treatment center onboarding, and ensuring compliance with regulatory standards for gene therapy operations.

BiotechnologyGeneticsMedicalTherapeutics

Comp. & Benefits

Hiring Manager

Sarah Oleson

Responsibilities

Develop and mentor a high performing Gene Therapy Operations, Apheresis team that is focused on delivering an excellent patient and stakeholder experience for commercial gene therapy from scheduling through infusion process

Develop and execute the strategic initiative and process for Treatment Center Qualification, training and ongoing support for patient coordination, scheduling, communication, cell collection support, and drug product infusion support

Drive Workflow & Training development: Design training to qualify apheresis and treatment centers, leading treatment center activation and certification processes and providing ongoing operational oversight post-activation

Quality & Compliance oversight: Ensuring compliance with regulatory standards (FACT, AABB), managing quality records (deviations, CAPAs, change controls) and overseeing the end-to-end process for patient apheresis and product delivery. Ensure COC/COI and assist in the implementation of ISBT-128 ST-018, as needed

Partner with Quality and Patient Operations team to build a robust treatment center network including center selection, qualification, training and ongoing support. Lead field team providing onsite support

Provide Apheresis expertise to support various internal activities and external facing training development

Create and conduct Apheresis and Cell therapy lab on-boarding, assessments, training, and collection support and other areas as needed

Build metrics program that will drive data collection and analysis in support of optimizing collection procedures, efficiency, and quality

Actively engage in the identification, sharing, and adaptation of best practices cross-functionally and between centers and identify and champion industry working group initiatives that will improve overall cell and gene therapy industry and treatment experience of our patients

Work closely across functions to ensure Chain of Identify and Chain of Custody are maintained throughout the patient journey

Qualification

Gene Therapy OperationsApheresis expertiseBiotech industry experienceQIA certificationSickle Cell Disease experienceGCPsGMPs knowledgeLeadership skillsCommunication skillsProblem-solving abilitiesTeam player

Required

Bachelor's degree or the combination of education and business experience required

Minimum 10+ years (18+ years) of healthcare or related experience, including significant experience within the biotech industry (especially with cell and gene therapy products)

Strong direct apheresis experience within the last 5 years

Ability to work independently with very limited supervision

Ability to navigate and be successful in a fast-paced, highly matrixed work environment

Detail-oriented, able to assess and assimilate data and communicate objectively

Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations

Effective teaching, training, planning, and problem-solving abilities

Willingness to travel domestically (30-50% of time)

Strong team player that has patient focused approach and is solution oriented

Excellent listening, communication and interpersonal skills foster team spirit

Excellent people management skills and a strong track record of developing people/talent and organizational capability

A passion for addressing the critical unmet medical needs of patients