Director of Operations

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Candidates must possess a Bachelor’s degree in Engineering, Life Sciences, or a related field, with an advanced degree (MS, MBA, or PhD) being preferred. A minimum of 12 years of combined experience is required in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation, or quality management, with a preference for Cell/Gene Therapy experience. Additionally, a minimum of 5 years of progressive leadership experience in a cGMP operation, preferably with Biologics and/or cell therapy operations, and prior experience leading large multilevel teams are necessary.

Responsibilities

The Director of Operations will oversee cell therapy production, ensuring safe and compliant manufacturing operations according to cGMP requirements within a 24/7 operation. This includes leading a large organization, managing personnel for daily production schedules, and overseeing hiring, development, and performance management for staff. The role involves responsibility for multiple work centers to ensure high quality and compliant product supply, monitoring production metrics, supporting manufacturing investigations, managing change controls, and maintaining inspection readiness. The Director will also lead operating review meetings, sponsor projects for continuous improvement, support organizational design and capacity ramp-up, and build partnerships with cross-functional teams. They will serve as the delegate for the Head of Operations and establish relationships with internal and external stakeholders.

Skills

Cell Therapy Production

cGMP

Manufacturing Operations

Staff Management

Performance Management

Hiring

Development

Production Scheduling

Sterile Manufacturing

Non-sterile Manufacturing

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Franklin Township, New JerseyHeadquarters

2014Year Founded

$146.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.

Collaboration with Multiply Labs may face technological challenges, delaying production timelines.

Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.

The company is technology agnostic, exploring multiple platforms for effective cancer treatments.

Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.

New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.

Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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