Location: Indianapolis, IN
Job Summary
The Manager, IT Digital Plant Applications & Automation is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Exec. Director, IT and be primarily responsible implementing RayzeBio’s vision for growth and leading efforts to enable digital processes to achieve commercialization objectives at the site. The role will ensure the digital systems applications along with CSV for lab and process automation are enabled and maintained to successfully deliver novel Radiopharmaceutical technologies. You will work with lab & process automation, large corporate systems, small biotech systems, across all functions for the Indianapolis site(s). Additional responsibilities will include working with architectural and IT partners and specialty equipment manufacturers to achieve our technology and commercialization goals.
Key Responsibilities:
- Responsible for continuous operation and maintenance of IT, lab & process automation systems (including MES, LIMS, local manufacturing, quality control and quality management site IT systems) as well as associated site infrastructure.
- Deliver to site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
- Work with service providers to deliver effective, innovative and stable solutions that meet the needs of the site.
- Support site regulatory inspection readiness and data integrity initiatives.
- Partner on new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology)
- Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site
- Support deployment of long-term (3 year) roadmaps identifying capabilities that have the greatest impact on business capabilities for the organization. Partnering and benchmarking with external sources.
Education and Experience:
- 3-5 years’ IT experience in a cGMP injectable or Radiopharmaceutical environment is required.
- Proven technical leadership and management experience.
- Demonstrated experience implementing automation and digitization projects.
- BS/MS Information Technology or similar degree or equivalent experience
Skills:
- Understanding of computer system validation.
- 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 pharma 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).
Please click here to apply.
