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Senior Director/Vice President, Technical Development

Somerville, Massachusetts, United States
 

About bluebird bio

At bluebird every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

  • Persist for Purpose
  • Be Compassionate
  • Stay humble and curious
  • Keep it real
  • Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

 

ABOUT US &

We are seeking a strategic and technically accomplished Head of Technical Development with deep expertise in CD34+ cell-based therapies to lead the development, optimization, and lifecycle management of manufacturing processes for our commercial pipeline. You will play a critical leadership role in defining and executing manufacturing strategy, overseeing internal and external development activities, and ensuring regulatory-compliant processes suitable for commercial production. You will also not only extensive cell therapy development experience but also proven success in leading comparability assessments to support manufacturing changes, regulatory submissions, and product lifecycle transitions for commercial-stage cell therapy products. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

  • Strategic Leadership: Lead the end-to-end process development strategy for CD34+ cell therapies, including apheresis handling, enrichment, activation, transduction, culture, and formulation. Lead development efforts for life cycle management of process improvements for CD34 cell therapy product.
  • Process Development & Optimization: Design and optimize process unit operations aligned with QbD principles.  Demonstrate clear understanding of CQA and CPP interactions in CD34+ cell therapy processes.
  • Comparability Strategy Execution: Lead and execute comparability strategies to support process changes, manufacturing site transfers, or raw material changes, with emphasis on regulatory expectations for commercial products. Collaborate with analytical and regulatory teams to establish meaningful acceptance criteria and data packages. Understanding of risk management strategy such as Q9(R1) Quality Risk Management.
  • CDMO Management: Direct technology transfer activities to CDMOs, ensuring robust and well-documented transitions. Lead interactions with contract development and manufacturing organizations to ensure alignment on scope, timelines, and quality standards.
  • Regulatory Support: Author and review CMC sections for FDA submissions. Represent Process Development in regulatory meetings and support responses to agency questions, with a focus on comparability packages and change management.
  • Cross-functional Leadership: Work closely with Analytical Development, MSAT, QA, Regulatory, and Clinical to align technical strategies with overall program objectives.
  • Team Building & Mentorship: Build and mentor a high-performing team of scientists and engineers to drive innovation and operational excellence.

QUALIFICATIONS

  • PhD or MS in Cell Biology, Immunology, Biomedical Engineering, or related field.
  • 10–15+ years of industry experience in bioprocess development, with at least 7 years in cell therapy, ideally involving CD34+ hematopoietic stem and progenitor cells.
  • Hands-on experience executing comparability strategies for process changes.
  • Experienced in OOS investigations, FMEA, risk assessment, CAPA, and RCA.
  • In-depth knowledge of regulatory expectations for comparability of late stage or commercial stage cell therapy product.
  • Experience with closed/automated systems (e.g., CliniMACS Plus, CliniMACS Prodigy, LOVO, Cue, Sepax). Use of control charts, regression, and statistical tools (e.g., JMP, Minitab, SIMCA) for data trending of process unit operations.
  • Demonstrated ability to lead cross-functional teams and manage external partnerships. Strong leadership in CDMO management and project management capabilities.

bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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