Simplify Logo

Full-Time

Senior Analytical Scientist I

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops cell therapies for cancer, autoimmune diseases

Hardware
Biotechnology

Senior, Expert

North Bethesda, MD, USA

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor’s degree with 10+ years of relevant work experience, or master’s degree with 8+ years’ experience, or PhD in relevant scientific discipline with 2+ years of postdoc or industry experience on protein or virus analysis.
  • Solid background knowledge and practical experience in biophysical techniques to characterize aggregates, subvisible and visible particles in proteins and/or viral vector products, such as flow imaging techniques, HIAC, NTA, SEC-MALS, FFF-MALS, DLS/SLS, etc.
  • Hands-on experience in thermodynamic analysis (DSC or DSF) to support formulation development or product characterization.
  • Prior experience in particle characterization and investigation in the late stage of CMC development is highly desired.
  • Experience in drafting and reviewing technical documents including analytical method SOPs, characterization protocols and reports.
  • Experience in applying Design of Experiment (DOE) and other appropriate statistics approaches during formulation development, analytical method development and robustness study is preferred.
  • Excellent collaborator with strong communication skills.
  • Proven self-starter with a high attention to scientific details and strong problem-solving skills.
Responsibilities
  • Serve as a biophysics SME (subject matter expert) in CMC activities including pre-formulation study, formulation development, in-process monitoring, product characterization, particle characterization and investigation.
  • Collaborate with a dynamic and engaging team of Arcellx scientists and CDMO partners to perform biophysical characterization and thermodynamic analysis on protein and lentivirus products.
  • Build strategies for protein or virus product quality analytical testing throughout the product lifecycle development.
  • Participate in designing long-term stability studies per regulatory guidelines and perform stability data trending analysis for drug substances, drug products and reference standards.
  • As a key contributor, design and coordinate accelerated and stressed stability study for manufacturability assessment, analytical method development, formulation development, CQA assessment and comparability study.
  • Author and review technical documents.
  • Perform and troubleshoot analytical assays to support CMC and some research activities.
  • Present scientific study design and findings at internal and external meetings.

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

16%

1 year growth

25%

2 year growth

76%
Simplify Jobs

Simplify's Take

What believers are saying

  • The Phase 3 iMMagine-3 trial for anito-cel could significantly boost Arcellx's market position if successful.
  • Recent robust long-term responses from the Phase 1 expansion trial of anito-cel indicate promising efficacy and safety, potentially leading to FDA approval.
  • The $285M equity investment and upfront cash from Kite provide substantial financial backing for Arcellx's ongoing and future projects.

What critics are saying

  • The competitive landscape for CAR T therapies is intense, with established players like Abecma and Carvykti posing significant challenges.
  • Regulatory hurdles, such as the recent FDA partial hold, could delay product development and market entry.

What makes Arcellx unique

  • Arcellx's anitocabtagene autoleucel (anito-cel) is the first BCMA CAR T therapy for multiple myeloma utilizing a novel D-Domain binder, setting it apart from existing treatments.
  • The company's strategic partnership with Kite, a Gilead Company, enhances its research capabilities and market reach, distinguishing it from smaller biotech firms.
  • Arcellx's focus on innovative immunotherapies for cancer and other incurable diseases positions it uniquely in the biotech landscape.