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

+ Bonus + Equity Grant

Expert

San Carlos, CA, USA

Relocation assistance is offered for roles if required.

Category
Computational Biology
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 improving cell therapy for serious diseases. Their products focus on advanced techniques that harness the body's immune system to fight illnesses. The company collaborates with healthcare providers and research institutions to create and commercialize these therapies, generating revenue through partnerships and product sales after regulatory approval. What sets Arcellx apart from competitors is its commitment to addressing unmet medical needs with proprietary treatments. The goal of Arcellx is to provide effective and safe options for patients requiring advanced medical care.

Company Size

51-200

Company Stage

IPO

Headquarters

Gaithersburg, Maryland

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Kite enhances development of anito-cel for multiple myeloma.
  • Positive Phase 1 results for CART-ddBCMA show robust long-term responses.
  • Growing interest in personalized medicine aligns with Arcellx's mission for safer therapies.

What critics are saying

  • Competition from Legend Biotech and Johnson & Johnson's Carvykti in multiple myeloma.
  • High R&D costs and potential delays in achieving profitability.
  • Dependence on partnerships, such as with Kite, poses strategic risks.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has 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 multiple myeloma cell targeting.

Help us improve and share your feedback! Did you find this helpful?

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

1%

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
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

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

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.