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Manager, Facility Operations jobs in United States
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Arcellx · 2 days ago

Manager, Facility Operations

Arcellx is a public, clinical-stage biotechnology company focused on engineering innovative immunotherapies for cancer patients. They are seeking a Manager of Facility Operations to lead and support cell therapy facility operations, ensuring compliance with cGMP requirements and overseeing the operationalization of their Clinical Manufacturing facility.
BiotechnologyHealthcarePharmaceuticalLife ScienceBiopharmaHealth Care
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Lead cell therapy facility operations support activities to ensure robust and safe production in compliance with cGMP requirements
Develop, review, and approve SOPs, protocols, and documents related to facilities operations, engineering, maintenance, and life cycle management
Coordinate with manufacturing for execution of discrete patient lots or healthy donor runs to deliver on pipeline/ clinical trial needs
Maintain KPI’s related to facility operations
Operate with Safety first, Quality always mindset
Support Facility related investigations, implement corrective actions, manage change controls, and support gap assessments for tech transfer activities
Oversee building systems, utilities, and space planning for manufacturing, and lab areas
Support proposed construction, facility qualification & modification projects as needed
Track facilities operations and manage equipment calibration and preventative maintenance
Assist in developing Business Continuity Processes for critical business systems, manufacturing, and lab processes

Qualification

CGMP complianceFacility operations managementFDA regulations knowledgeOperational Excellence principlesCollaboration skillsCommunication skillsProblem-solving skills

Required

Bachelor's degree in biological sciences, chemical, bioengineering, mechanical or electrical engineering (or equivalent combination of education and experience)
Minimum 8 years of manufacturing and/or facility operations support experience in the biotechnology or pharmaceutical industry. Candidates with more experience may be considered at the senior manager level
Strong knowledge/ understanding of FDA regulations (GMP's), industry standards, and cGMP Quality systems
Thrives in a fast-paced, dynamic environment. Can manage shifting priorities to meet critical deadlines while providing clear direction to team members
Demonstrates strong collaboration, communication, collaboration, and problem-solving skills

Preferred

Proficiency in Operational Excellence principles/ initiatives to implement continuous improvement in manufacturing is a plus

Benefits

100% coverage for medical, dental and vision for team members and dependents
Unlimited vacation
A 3-day weekend every month
Fully-paid parental leave for up to 6 months
Tuition reimbursement
401k employer contribution
Relocation assistance

Company

Arcellx

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Arcellx is a clinical-stage biotechnology company that provides patients with immune cell therapies.

H1B Sponsorship

Arcellx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2022 (2)

Funding

Current Stage
Public Company
Total Funding
$622M
Key Investors
Kite PharmaCAM Capital,Samsara BioCapitalAju IB Investment,Quan Capital
2023-11-15Post Ipo Equity· $200M
2022-12-09Post Ipo Equity· $100M
2022-06-15Post Ipo Equity· $112M

Leadership Team

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Michelle Gilson
Chief Financial Officer
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Brad Gliner
Vice President, Clinical Research and Regulatory Affairs
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Company data provided by crunchbase