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BeOne

Global oncology therapeutics discovery, development, manufacturing

Associate Director - Manufacturing IT Systems

IT OperationsConfirmed live in the last 24 hours
Full-timeHopewell, NJ, USA

About the Job

Requirements

  • Extensive knowledge of complex, GxP manufacturing facilities and a strong understanding of Good Manufacturing Practice (GMP) and GAMP 5.
  • Experience authoring and approving validation documents.
  • Familiarity with MES, E-Logbooks, DCS, SCADA, BMS, EMS, and asset management systems.
  • Understanding of networks, firewalls, data centers, virtualized environments, and distributed infrastructures.
  • Experience with Industry 4.0 technologies and a proficient understanding of ISA 95 standards.
  • Knowledge of Allen Bradley and Siemens PLCs, as well as Aveva PI historian.
  • Understanding of equipment used in weighing and dispensing, granulation, tableting, and coating processes.
  • Strong communication and executive presentation abilities.
  • Excellent interpersonal skills for effective teamwork.
  • Diplomacy and the ability to rationalize multiple points of view.
  • A bachelor's degree in information technology, computer science, engineering, or a related field.
  • At least 8 years of experience in IT management or leadership roles.
  • Experience in project management, budget control, Lean Six Sigma, and Green Belt training and application.
  • Proficiency with Windows Server AD, AWS, network infrastructure, MS-SQL, Smartsheet, and Veeva.

Responsibilities

  • Oversee the construction, validation, and support of IT systems for Small Molecule Plant operations.
  • Supervise the design, construction, validation, and integrity of IT infrastructure, including LAN, networking equipment, and servers.
  • Install, validate, and maintain IT devices and equipment in quality control laboratory and manufacturing plant environments.
  • Provide technical direction and manage projects with minimal supervision.
  • Act as the primary IT interface for identifying and prioritizing new site development requests.
  • Collaborate with manufacturing and quality teams to ensure the new plant operates reliably and efficiently in a 24/7 commercial manufacturing environment.
  • Partner with project teams and Global IT counterparts to establish a GxP-compliant environment.
  • Collaborate with Engineering and quality assurance teams to assess and enhance system data integrity, security, and system integration.
  • Ensure adherence to corporate IT strategies and standards, recommending changes when necessary.
  • Configure system backups and recovery protocols.
  • Deliver technology services that enhance business processes.
  • Implement the IT vision and advance company systems, processes, and infrastructure.
  • Introduce new technologies to support future growth.
  • Supervise contractors and project resources.
  • Travel occasionally to other company sites and vendor sites.

Desired Qualifications

  • Pharmaceutical or biotechnology industry experience, particularly in mid-size plants.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

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