Senior Advisor, Advanced Therapies Manufacturing

BioSpace

Indianapolis (IN)

Presencial

USD 152.000 - 264.000

Tempo integral

Há 9 dias

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Benefícios oferecidos por esta vaga

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Resumo da vaga

Lilly, a global healthcare leader headquartered in Indianapolis, Indiana, seeks a Senior Advisor/Director/Senior Director – Technical Services/Manufacturing Science, Advanced Therapies to drive technical strategy for viral vector and lipid nanoparticle programs. You will partner with development teams, oversee manufacturing readiness, and contribute to regulatory submissions.

This role requires an advanced degree and 8+ years in biopharma manufacturing or technical services, with hands-on

Qualificações

Master’s or PhD in a related scientific discipline.
Minimum of eight years in biopharmaceutical drug substance manufacturing, process development or technical services in GMP.
Hands-on experience with advanced therapy modalities (viral/vector or lipid nanoparticle/mRNA).

Responsabilidades

Define and own product control strategy with development orgs.
Represent TS/MS on cross-functional teams for manufacturing readiness and process validation.
Provide oversight of external contract manufacturers and tech transfer.
Author/review CMC regulatory submissions and responses.
Lead viral vector and lipid nanoparticle manufacturing technical leadership.
Collaborate on potency, infectivity, and cryogenic handling strategies.
Lead complex process investigations and change controls.
Ensure state of control with QA/QC functions.
Teach and mentor scientists across the network.