Director/Senior Director, Apheresis Operations

Company Overview

Beam Therapeutics is 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 a highly talented and motivated (Senior) Director, Apheresis Operations for ex vivo therapeutics.  This role will create and build a new Apheresis Operations function within Patient Supply.  This will foster close communication with cross function Beam Team members such as Medical, Clinical Operations, Product Development, Manufacturing, and Quality Assurance. 

Responsibilities:

• Build new Apheresis Operations function that is focused on delivering excellent patient and stakeholder experience for clinical trials as it relates to the collection of patient cells.
• Partner with clinical, quality, patient supply teams to build a robust collection network to support internal portfolios including:
  • Site selection, technical assessments training and onsite support.
  • Communicate and implement changes which affect apheresis site operations while aligning with regulatory authorities as required.
• Serve as a key member of the clinical development team and optimize study documents (eg. protocol and cell handling manuals) to increase cell collection.
• Provide apheresis expertise to support various internal activities such as regulatory submissions, protocol development and other quality processes.
• Create and conduct Apheresis and Cell therapy lab on-boarding, assessments, training, and collection support and other areas as needed. Assist in the implementation of ISBT-128 ST-018, 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 clinical trial sites.
• Work closely with the Patient Supply, Supply Chain, Manufacturing, Quality, and Clinical functions to ensure the Chain of Identity of patient cell collection through the patient treatment pathway.
• Identify and champion industry working group initiatives that will improve the overall Cell and Gene Therapy Industry and the treatment experience of our patients.
• Coach, develop and mentor a high-performing team with a vision of setting industry-leading standards.

Qualifications

• Bachelor's degree or the combination off education and business experience required.
• Advanced degree preferred (e.g., MBA, RN, MPH, etc.)
• Minimum 10+ years (15+ years) of healthcare or related experience, including significant experience within the biotech industry (especially with cell and gene therapy products).
• Strong preference for experience within Sickle Cell Disease and autologous cell & gene therapy.
• Strong direct apheresis experience within the last 5 years.
• 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 conducting clinical trials and working with clinical research teams
• Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations
• Effective teaching, training, planning, and problem-solving abilities
• Willingness to travel domestically (~10-25% 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 with multicultural background and a strong track record of developing people/talent and organizational capability.
• A passion for addressing the critical unmet medical needs of patients.