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Associate Director/CDMO/business operations engineering/cGMP

Maxis Clinical Sciences
Vacaville, CA Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/30/2025

Job Description

Job Description

CDMO industry, business operations engineering and cGMP Manufacturing of chemical and biological API

We are now seeking an Associate Director, Project Delivery. This role offers an outstanding opportunity to lead investment projects with a top-tier team in a dynamic and growing environment. Will contribute to innovative projects that support life sciences and have a positive impact on global health.

Key Responsibilities

  • Develop and complete project plans, ensuring timely and budget-friendly completion through Engineering, Design, Construction, Commissioning, and Qualification phases.
  • Manage project budgets, ensuring strict adherence and coordinating any necessary adjustments.
  • Ensure safety, quality, and compliance standards are met according to internal procedures and health authority requirements.
  • Coordinate project teams to guarantee efficient collaboration and flawless project execution.
  • Monitor project progress regularly, identifying and addressing potential issues promptly.
  • Ensure compliance with all relevant regulations and legal requirements.
  • Identify project risks and develop effective mitigation strategies.
  • Communicate project status, progress, and issues to collaborators and senior management, including presenting updates at Steering Committee meetings.
  • Manage project resources, including equipment, materials, and personnel.
  • Develop and maintain relationships with vendors and contractors to ensure high-quality work and timely project delivery.
  • Lead, mentor, and coach teams with or without direct line responsibility.
  • Familiarity with modern CQV approaches to minimize construction-to-production timelines while maintaining compliance.

Key Requirements

  • Bachelor's degree in chemical engineering, mechanical engineering, electrical engineering, or a related field.
  • Proficiency in Spanish is highly preferred.
  • Extensive experience in project engineering and management within the chemical, biochemical, and life sciences industries.
  • Broad technical knowledge of various engineering fields in life sciences, including clean and black utilities, process, automation, instrumentation, and civil engineering.
  • Proven experience in cost control and scheduling for investment projects.
  • Proficiency in computer systems such as Microsoft Word, Excel, PowerPoint, and Visio.
  • Strong experience and understanding in the CDMO industry, business operations engineering and cGMP Manufacturing of chemical and biological APIs.
  • Company Description

    Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12 years of average experience.

    Our popular service niches that earned us global accolades are : clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.

    Company Description

    Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12 years of average experience. Our popular service niches that earned us global accolades are : clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.

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