Senior Bioassay Lead for RNA-LNP Therapies

100 Eli Lilly and Company

Boston (MA)

On-site

USD 141,000 - 231,000

Full time

3 days ago
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Benefits offered by this job

401(k) plan
Medical, dental, vision benefits
Paid time off
Career development programs

Job summary

Lilly is seeking an accomplished Senior Advisor for bioassay development to lead the analytics strategy for RNA-LNP programs within ADS. You will direct bench scientists, serve as SME for cell-based potency assays, and partner across Research, Process and Formulation, and Quality to advance analytical strategies from research to manufacturing.

The role requires hands-on bench skills, leadership, and a strong track record in bioassay/potency assay development and regulatory awareness.

Qualifications

  • PhD or equivalent with bioassay experience.
  • Hands-on development of cell-based potency assays.
  • Experience with flow cytometry, qPCR/ddPCR and ELISA.
  • Knowledge of ICH/FDA guidelines for bioassays.
  • Experience transferring assays to internal/external labs.

Responsibilities

  • Define and execute bioassay strategy and roadmap.
  • Lead end-to-end development and transfer of cell-based potency assays.
  • Design and implement cellular and molecular assays including flow cytometry, qPCR/ddPCR, and ELISA.
  • Represent bioassay on cross-functional project teams and act as SME for potency topics.
  • Establish assay comparability and bridging across changes; apply DOE to reduce variability.
  • Ensure analytical strategies meet regulatory expectations and enable transitions from research to manufacturing.

Skills

Bioassay development
Cell-based potency assays
Flow cytometry
qPCR/ddPCR
ELISA

Education

PhD in molecular biology/biochemistry
MS with 10+ years experience

Tools

CDMOs collaboration
DOE design

Job description

Lilly is seeking an accomplished Senior Advisor for bioassay development to lead the analytics strategy for RNA-LNP programs within ADS. You will direct bench scientists, serve as SME for cell-based potency assays, and partner across Research, Process and Formulation, and Quality to advance analytical strategies from research to manufacturing.

The role requires hands-on bench skills, leadership, and a strong track record in bioassay/potency assay development and regulatory awareness.

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