Manager, Business Systems & Electronic App

The Company

Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Our facility in San Antonio, Texas specializes in working with start-ups, emerging biotechs, and academic researchers. Scorpius was founded by a serial biotech entrepreneur determined to make small-volume programs a big priority. Clients benefit from decades of expertise taking large molecule drugs to market and can rely on Scorpius to offer Quality, Speed, Flexibility, & Responsiveness.

Position Summary

Reporting to the Head of Operational Excellence, this position will oversee Electronic Applications within our rapidly growing biomanufacturing company. The successful candidate will be responsible for developing and executing strategy, managing internal and external support professionals, and ensuring the seamless integration of technology solutions to support our operations and drive innovation at Scorpius BioManufacturing.

Key Responsibilities

• Responsible to identify technology gaps, execute application improvement meeting current trends, to mitigate risks while improving company efficiencies that could impact the company's future growth and competitiveness.
• Responsible for effectively coordinating the organization's internal and potential external stakeholders in developing application related solutions.
• Provide strategic insights and recommendations on related investments, resources, and priorities.
• Responsible for hands-on implementation of applications and strategy to coordinate with company network owner for infrastructure security.
• Work directly with business, operations and quality team members to ensure reliability, availability, and performance of IT systems.
• Oversee IT Data Integrity Governance programs for both Enterprise and Standalone GMP applications.
• Implement and enforce application best practices to maintain security and compliance with industry regulations.
• Implement robust cybersecurity measures to protect the company's sensitive information and data assets.
• Partner with the Quality Department to ensure related solutions meet regulatory requirements.

Education & Experience

• Bachelor's degree in Sciences preferably Information Technology, Computer Science, or a related field.
• Minimum of 5 years of relevant & progressive experience, preferably in a pharma/biomanufacturing or pharmaceutical environment.

Knowledge & Skills

• Understanding of biomanufacturing processes and regulatory requirements is preferred.
• Proven track record of successfully developing and executing IT strategies that drive business growth and operational excellence.
• Experience in managing IT teams and fostering a collaborative and innovative work culture.
• In-depth knowledge of infrastructure, networking, cybersecurity, and enterprise applications.
• Excellent communication and interpersonal skills, with the ability to communicate complex technical concepts to non-technical stakeholders.
• Experience with 21 CFR Part II and FDA guidance documents on the principles of software validation.
• Experience in implementing and leading change management and governance process, as well as owning deviations and change control in a regulated environment.

Physical Requirements & Working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds.