Cell Therapy Specialist I/II at Arcellx

Redwood City, California, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Cell TherapyIndustries

Requirements

Bachelor’s degree in a relevant scientific field and 5+ years of industry experience in cell therapy manufacturing
Excellent aseptic techniques and experience with cell processing equipment
Ability to operate within a clean room environment for long durations
Understanding of GMP principles and cleanroom operations
Excellent organizational and prioritization skills
Exceptional collaboration, communication, and interpersonal skills
Flexibility to work weekends, holidays, or shift schedules as required

Responsibilities

Accurately follow manufacturing batch records (MBRs) and standard operating procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs)
Execute end-to-end cell therapy manufacturing operations including: operation of manufacturing equipment for batch production, media preparation, reagent handling, buffer preparation, aseptic processing in controlled cleanroom environments
Provide technical support for T-cell manufacturing process changes, process validation, discrepancy/deviation, and investigation evaluation
Document all activities in accordance with Good Documentation Practices (GDPs)
Author and review documents including MBRs, protocols, deviation reports, and SOPs
Participate in risk assessments, gap/facility fit analysis, deviation investigations, change controls, CAPAs, and root-cause analysis
Maintain strict compliance with regulatory and internal quality standards
Perform routine maintenance activities required for a GMP environment
Partner closely with MSAT, QA, QC, Supply Chain, and Facilities teams

Skills

cGMP

cell therapy manufacturing

batch records

SOPs

biomanufacturing

Arcellx

Develops immunotherapies for cell therapy

About Arcellx

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the effectiveness of treatments. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Gaithersburg, MarylandHeadquarters

2014Year Founded

$194.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

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

Risks

Competition from established CAR-T therapies like Abecma and Carvykti could limit market share.

Dependency on Gilead's Kite partnership poses risks if partnership dynamics change.

Phase 3 iMMagine-3 trial delays or failures could impact anito-cel's market timeline.

Differentiation

Arcellx's CART-ddBCMA has FDA Fast Track and Orphan Drug designations.

The novel D-Domain binder in anito-cel enhances antigen binding and cell killing.

ARC-SparX offers dosable and controllable CAR-T therapy options.

Upsides

Growing investment in personalized medicine aligns with Arcellx's tailored immunotherapies.

Advancements in gene editing like CRISPR enhance precision in engineered cell therapies.

Outpatient CAR-T administration could reduce costs and increase accessibility for Arcellx.

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