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Full-Time

Director – Analytical Development

Posted on 3/22/2024

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Hardware
Biotechnology

Senior, Expert

North Bethesda, MD, USA

Category
Computational Biology
Genomics
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • PhD. or master's degree in immunology and cellular biology or a related discipline.
  • 8+ years (with PhD) or 12+ years (with MS) of experience in late-stage analytical development for cell therapeutics.
Responsibilities
  • Design and execute method development and qualification in support of process development, product release and stability, product characterization, investigation, and process performance qualification.
  • Direct phase-appropriate assay development, qualification, and transfer for starting material, raw material, drug substance and drug product.
  • Oversee analytical technical activities at a CDMO in support of product development on accelerated timelines, including late-stage product characterization, risk assessments, and establishment of QTPP and control of CQAs.
  • Prepare and review documents in support of CMC Regulatory IND filings and address queries from health authorities.
  • Guide the analytical team to support career growth and development in experiment design, data analysis, documentation, and communication/reporting.

Arcellx develops innovative cell therapies for cancer and autoimmune diseases, leveraging their novel D-Domain technology and transformative ddCAR and ARC-SparX platforms to enhance cell therapy.

Company Stage

N/A

Total Funding

$736M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

5%

1 year growth

13%

2 year growth

63%
INACTIVE