Director, Analytical Development – RNA-LNP & Gene Therapies

BioSpace

Boston (MA)

Presencial

USD 168.000 - 264.000

Jornada completa

hace 38 horas
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Ventajas ofrecidas por este puesto de trabajo

401(k) plan
Pension
Vacation benefits
Medical, dental, vision benefits
Well-being benefits

Descripción de la vacante

Lilly is seeking a senior leader to build and direct the analytical development team within the Advanced Delivery Systems organization, supporting RNA‑LNP therapies and other delivery innovations. The role partners with multiple R&D and manufacturing units to advance Lilly’s transformative pipeline.

The ideal candidate will combine scientific depth, strategic leadership, and operational excellence in a fast‑paced environment, with a track record in LC‑MS and bioassays and a strong record of

Formación

  • PhD in biochemistry/analytical chemistry/molecular biology with 10+ years industry experience in assay development.
  • 5+ years in a leadership role leading analytical development teams.
  • Deep hands-on experience with LC‑MS and separation sciences for characterizing mRNA, protein and lipid components in RNA/LNP products or related bioassays.
  • Proven experience in phase-appropriate assay development, qualification, and transfer for lot release and stability.
  • Strong understanding of ICH guidelines and cell/gene therapy best practices.
  • Excellent communication and problem‑solving skills to influence scientific direction.

Responsabilidades

  • Establish vision and roadmap for analytical development, including RNA‑LNP platforms.
  • Provide organizational leadership aligned with company objectives.
  • Recruit, mentor, and retain scientific talent.
  • Collaborate with research, formulation, process, manufacturing, quality, and regulatory teams to define product CQAs and enable tech transfer.
  • Lead development, optimization, and qualification of analytical methods for release, stability, and comparability testing.
  • Drive innovative solutions to characterize RNA cargos, lipids, and nanoparticles under regulatory expectations.
  • Prepare technical reports and contribute to regulatory submissions and agency interactions.
  • Identify external collaborations to enhance capabilities and represent the company at scientific meetings.

Conocimientos

Communication
Prioritization
Problem-solving

Educación

PhD in biochemistry/analytical chemistry/molecular biology

Herramientas

LC-MS
Flow cytometry
Bioassays (ELISA, PCR)

Descripción del empleo

Lilly is seeking a senior leader to build and direct the analytical development team within the Advanced Delivery Systems organization, supporting RNA‑LNP therapies and other delivery innovations. The role partners with multiple R&D and manufacturing units to advance Lilly’s transformative pipeline.

The ideal candidate will combine scientific depth, strategic leadership, and operational excellence in a fast‑paced environment, with a track record in LC‑MS and bioassays and a strong record of

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