Full-Time

Principal QC Specialist

Updated on 1/14/2025

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Biotechnology
Healthcare

Compensation Overview

$140k - $170kAnnually

+ Bonus + Equity Grant

Senior, Expert

San Carlos, CA, USA

Relocation assistance is offered if required.

Category
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor’s degree in relevant field (e.g. immunology, cellular biology and molecular biology). Advanced degree preferred.
  • Minimum of 12 years (with BS), 10 years (with MS), or 7 years (with PhD) of experience in Quality Control or related areas within the biotech or pharma companies.
  • Expertise in molecular-based assays.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines.
  • Strong collaboration, communication, and interpersonal skills. Demonstrated ability to influence within a matrix team structure.
  • Strong knowledge of cGMP/ICH/FDA regulations.
Responsibilities
  • Collaborate with teammates to develop and build our new QC testing laboratory from the ground up.
  • Establish sample management and chain of custody program, laboratory management system, and data backup system.
  • Perform technical review of GMP method qualification, method transfer, analytical testing associated with the batch release, stability and product characterization.
  • Draft and develop QC related SOPs, protocols, reports, impact assessments and root cause analysis.
  • Be a Subject Matter Expert (SME) for the QC assays, especially molecular based assays.
  • Lead and approve for QC GMP Quality Management Systems, including Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls.
  • Coordinate activities to establish equipment/instrument qualification and validation program to meet the quality standards.

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products work by harnessing the body's immune system to target and treat conditions that currently have limited treatment options. Unlike many competitors, Arcellx focuses specifically on proprietary immunotherapy products and has a business model that includes partnerships and licensing agreements to support their research and development efforts. The company's goal is to meet unmet medical needs by providing safe and effective treatment alternatives for patients.

Company Stage

IPO

Total Funding

$194.5M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

4%

1 year growth

0%

2 year growth

1%
Simplify Jobs

Simplify's Take

What believers are saying

  • Strategic partnership with Kite accelerates development and commercialization of therapies.
  • FDA support expedites approval process for Arcellx's innovative treatments.
  • Advancements in gene editing enhance precision of Arcellx's cell therapies.

What critics are saying

  • Competition from established CAR-T therapies like Abecma and Carvykti.
  • Dependency on Kite partnership could pose risks if dynamics change.
  • Phase 3 trial for anito-cel carries risk of not meeting endpoints.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has FDA Fast Track, Orphan Drug, and RMAT designations.
  • The ARC-SparX platform offers dosable and controllable CAR-T therapy options.
  • Anito-cel uses a novel D-Domain BCMA binder for enhanced antigen binding.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Flexible Work Hours

401(k) Company Match

Fully-Paid Parental Leave

Tuition Reimbursement

Relocation Assistance