Associate Director, Small Molecule Plant IT Systems
BeiGene
Summary
As a key member of the site IT team at BeOne Medicines' Hopewell, NJ facility, this role is centered on supporting the design, construction, and validation of IT infrastructure and systems for a greenfield Small Molecule Pharma plant. Responsibilities encompass overseeing project delivery, supporting project teams, maintaining and strengthening stakeholder relationships, and driving operational excellence. As part of the Global Technology Services (GTS) team, the candidate will be instrumental in advancing systems, processes, and infrastructure in alignment with Pharma 4.0 initiatives to support and drive the company’s growth.
Job description
Essential Functions
IT Infrastructure and Support
- Oversee the construction, validation, and support of IT systems specific to 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 QC lab and manufacturing plant environments.
Project Management and Collaboration
- Work independently to provide technical direction and manage projects with minimal supervision.
- Act as the primary IT interface to identify and prioritize new site development requests.
- Work collaboratively with manufacturing and quality teams to ensure the new plant operates reliably and efficiently in a 24/7 commercial manufacturing environment.
Compliance and Security
- Partner with project teams and Global IT counterparts to establish a GxP-compliant environment.
- Collaborate with Engineering and QA 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.
Technology Advancement
- Play a key role in delivering technology services that enhance business processes.
- Implement the IT vision and advance the company's systems, processes, and infrastructure.
- Introduce new technologies in a dynamic environment, supporting future growth.
Experience and Knowledge
- Extensive knowledge of complex, GxP manufacturing facilities and strong understanding of Good Manufacturing Practice (GMP) and GAMP 5.
- Experienced in authoring and approving validation documents.
- Familiarity with systems such as MES, E-Logbooks, DCS, SCADA, BMS, EMS, and asset management.
- Understanding of networks, firewalls, and data centers, with experience in virtualized environments and distributed infrastructures.
- Experience with Industry 4.0 technologies and proficient understanding of ISA 95 standards.
Technical Skills
- 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.
Soft Skills
- Strong communication and executive presentation abilities.
- Excellent interpersonal skills for effective teamwork.
- Diplomacy and capability to rationalize multiple points of view.
Minimum Requirements – Education and Experience
- Bachelor’s degree in information technology, Computer Science, engineering or related field
- 8+ years in IT management or leadership roles, with a preference for experience in pharmaceutical manufacturing, particularly in mid-size plants.
Other Experience
- Project Management, Budget Control, Lean Six Sigma, Greenbelt training and experience
Supervisory Responsibilities
Supervise contractors and project resources
Travel
Occasional visits to other BeOne sites, Vendor sites
Computer Skills
Proficiency with Windows Server AD, AWS, Network Infrastructure MS-SQL, Smartsheet, Veeva
Requirements
- Bachelor’s degree in information technology, Computer Science, engineering or related field
- 8+ years in IT management or leadership roles
- Extensive knowledge of complex, GxP manufacturing facilities
- Strong understanding of Good Manufacturing Practice (GMP) and GAMP 5
- Experienced in authoring and approving validation documents
- Familiarity with systems such as MES, E-Logbooks, DCS, SCADA, BMS, EMS, and asset management
- Understanding of networks, firewalls, and data centers
- Experience in virtualized environments and distributed infrastructures
- Experience with Industry 4.0 technologies
- Proficient understanding of ISA 95 standards
- Knowledge of Allen Bradley and Siemens PLCs
- Knowledge of 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 capability to rationalize multiple points of view
- Project Management
- Budget Control
- Lean Six Sigma, Greenbelt training and experience
- Proficiency with Windows Server AD, AWS, Network Infrastructure MS-SQL, Smartsheet, Veeva
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.