Recrutement Katalyst HealthCares Irvine, CA

Recrutement Global Regulatory CMC Manager

Katalyst HealthCares & Life Sciences - Irvine, CA

Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio......

11 octobre 2025

Recrutement Medical Device Design Engineer

Katalyst HealthCares & Life Sciences - Irvine, CA

Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are: Lead and drive exe......

2 octobre 2025

Recrutement Clinical Data Manager

Katalyst HealthCares & Life Sciences - Irvine, CA

Job Description: The Clinical Data Manager (CDM) will oversee the planning, coordination, and execution of clinical data management activities across multiple studies in compliance with regulatory standards, Good Clinical Practice (GCP), a......

2 octobre 2025

Recrutement Lead Clinical Data Manager

Katalyst HealthCares & Life Sciences - Irvine, CA

Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data m......

1 octobre 2025

Recrutement Sr. SAS Programmer

Katalyst HealthCares & Life Sciences - Irvine, CA

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f......

26 septembre 2025

Recrutement Validation Engineer

Katalyst HealthCares & Life Sciences - Irvine, CA

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execut......

26 septembre 2025

Recrutement Sr SAS Programmer

Katalyst HealthCares & Life Sciences - Irvine, CA

Responsibilities: Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the stu......

26 septembre 2025

Recrutement Manufacturing Engineer(SME)

Katalyst HealthCares & Life Sciences - Irvine, CA

Roles & Responsibilities: Highly skilled manufacturing or industrial engineers with 12+ years of experience. Experienced with process development and done manufacturing site audits. Executed cost and quality improvement projects, y......

26 septembre 2025

Recrutement Component Engineer – Validation (IQ/OQ/PQ)

Katalyst HealthCares & Life Sciences - Irvine, CA

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to man......

26 septembre 2025

Recrutement Sr.Clinical Data Manager

Katalyst HealthCares & Life Sciences - Irvine, CA

Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin......

26 septembre 2025