Full-Time

Principal QC Specialist

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Compensation Overview

$140k - $170k/yr

+ Annual Bonus + Equity Grant

Senior, Expert

San Carlos, CA, USA

Relocation assistance is offered for roles 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.
Desired Qualifications
  • Advanced degree preferred.

Arcellx develops immunotherapies aimed at transforming cell therapy for serious diseases. The company focuses on creating proprietary products that utilize advanced cell therapy techniques. Their approach involves extensive research and development, leading to the commercialization of these therapies once they receive regulatory approval. Arcellx primarily serves healthcare providers, research institutions, and patients seeking effective treatments. Unlike many competitors, Arcellx emphasizes addressing unmet medical needs through its specialized expertise in cell therapy. The company's goal is to provide safe and effective treatment options for patients suffering from serious conditions.

Company Size

51-200

Company Stage

IPO

Headquarters

Gaithersburg, Maryland

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Gilead expands CART-ddBCMA development for lymphomas.
  • Advancements in gene editing enhance Arcellx's product precision and efficacy.
  • FDA's expedited approval pathways could accelerate Arcellx's market entry.

What critics are saying

  • Competition from Legend Biotech and Johnson & Johnson in multiple myeloma therapies.
  • Potential clinical trial delays due to patient recruitment challenges.
  • Financial dependency on partnerships and licensing agreements poses risks.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has FDA Fast Track and Orphan Drug designations.
  • ARC-SparX offers dosable and controllable CAR-T therapy, enhancing treatment flexibility.
  • Focus on innovative immunotherapies aligns with the trend towards personalized medicine.

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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

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

4%
Business Wire
Mar 20th, 2025
Arcellx Appoints Andrew Galligan and Kristin Myers to Its Board of Directors

Arcellx appoints Andrew Galligan and Kristin Myers to its Board of Directors.

BioSpace
Feb 28th, 2025
Arcellx To Participate At The Td Cowen 45Th Annual Health Care Conference

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, at 1:10 p.m. ET.A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx’s mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible

Business Wire
May 9th, 2024
Kite And Arcellx Continue Momentum With Advances In Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder. The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody

Business Wire
May 9th, 2024
Arcellx And Kite Continue Momentum With Advances In Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. SANTA MONICA, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder. The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody

Yahoo Finance
Mar 2nd, 2024
Earnings Update: Arcellx, Inc. (NASDAQ:ACLX) Just Reported And Analysts Are Boosting Their Estimates

Arcellx, Inc. (NASDAQ:ACLX) just released its full-year report and things are looking bullish.