Please login/register to apply for this job.
24 Aug 2021

Temporary Senior Manager IT Site Shared Services (21-25471)

iris.chen@axelon.com Bothell, Washington, United States

Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: PURPOSE AND SCOPE OF POSITION:
The Lead – IT Site Shared Services Senior Manager – Cell Therapy Manufacturing Systems supports
the successful operation of manufacturing and business functions at multi‐use sites through interaction with internal team members, peer and higher level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. The individual will answer questions and resolve IT issues for manufacturing and manufacturing support staff.

Reporting into the IT organization the candidate will be primarily responsible for owning and managing the IT shared landscape across the site IT systems, as well as be the Cell Therapy IT Cybersecurity Point of Contact (POC) and own the system patching effort for various local IT systems.

The candidate should have at least 10 years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing and Quality System disciplines. The candidate needs to have an
understanding of shop floor activities, Good Manufacturing Practices (GMPs), and process automation
in addition to prior experience in IT Architecture and Infrastructure networks.

REQUIRED COMPETENCIES:
Education: Bachelor’s degree in an engineering or MIS discipline
Experience:
• Must have experience with Cybersecurity, patching and IT Life Cycle Management (LCM) in a bio-tech manufacturing environment.
• Must have 10+ years of hands-on experience in a biotech manufacturing and supply chain environment

• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).

• Working knowledge of regulatory requirements and how they relate to existing and new
• business systems and practices, primarily GxP.

• Sound understanding of a Cell Therapy manufacturing facility IT Architecture and ITInfrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.

Knowledge, Skills, and Abilities:
• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding: Teamwork and collaboration. Client focus. Verbal and written communication
• Knowledge of Cell Therapy Facility (CTF) IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM).
• Understanding of computer system validation.

DUTIES AND RESPONSIBILITIES:
• Own and manage the IT shared landscape across the Cell Therapy site IT systems like IT
Architecture and IT Infrastructure including Network, Servers, HMIs, Printers, Scanners,
Switches, Firewall rules, Domains, etc.
• Own the IT Life Cycle Management (LCM) program as well as the roadmap for all the
above listed IT Infrastructure.
• Be the CTF IT Cybersecurity Point Of Contact (POC) and own the system patching effort
for various local IT systems.
• Monitor, track and reduce ServiceNow tickets related to IT Infrastructure.
• Manage spares and inventory for IT Infrastructure.
• Own the Disaster Recovery of local computerized systems and be the main POC during P1 and P2 ServiceNow tickets
• Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR-T Manufacturing.

WORKING CONDITIONS (US Only):
Office environment, seated majority of time. Must be able to move equipment (up to 25lbs).
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Additional Job Requirements:
None

How to Apply

Please share Resumes to Iris.chen@axelon.com to apply

Job Types: Temporary.

Job expires in 21 days.

70 total views, 1 today

Apply for this Job