Beam Therapeutics logo
Beam Therapeutics

Our vision is to provide life-long cures for patients suffering from serious diseases.

Senior Director, Gene Therapy Operations – Apheresis

TherapistTherapistFull TimeRemoteSeniorTeam 501-1,000Since 2017H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

$260K - $320K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

• 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.

Job Requirements

  • Bachelor's degree or the combination of education and business experience required.
  • Advanced degree preferred (e.g., MBA, RN, MPH, etc.)
  • 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.
  • Strong preference for experience within Sickle Cell Disease and autologous cell & gene therapy.
  • Qualification in Apheresis (QIA) certification preferred.
  • 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.
  • Experience in commercial gene or cell therapy is greatly preferred.
  • 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.

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