R&D Systems Analyst

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking an R&D System Analyst to join our growing IT Enterprise Applications team.  This role will directly support R&D functions (including Clinical Operations, Clinical Development, Quality, Regulatory, and Biometrics) by driving system/business process optimization, managing system change controls, and supporting computer system validation (CSV) activities in a GxP-regulated environment. This role is centered around applications and tools used to oversee and document clinical trials, as well as the processes to collate and submit to health authority agency(s).

This role will serve as a key partner to both IT and R&D business stakeholders, ensuring our enterprise applications meet operational needs and regulatory requirements.  This position reports to the Associate Director, GxP R&D Systems within the IT Enterprise Applications team and plays a critical role in the lifecycle management of R&D systems such as Veeva Vault and other cloud-based applications.

Key Responsibilities

System & Business Process Analysis

• Partner with business teams to define business process(es) & user requirements
• Support definition of project scope and deliverables to support business goals
• Identities and troubleshoots technical and system/process issues to resolution
• Provide training/orientation/qualification to internal users when required

Change Control & Release Management

• Oversee vendor managed services resources
• Act as a liaison across R&D teams to ensure the highest level of quality customer service and product delivery

CSV & Compliance

• Participate in the authoring/review and execution of implementation plans/qualification tests
• Participate in the authoring/review of computerized system validation (CSV) documentation
• Execute and coordinate UAT cycles across GxP systems

System Administration and Enhancements

• Support enhancements, triage requests and backlog management
• Deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization
• Ensure assignment and timely resolution of account requests, user issues and change requests
• liaise with computer system vendors, IT partners, Validation and the business to coordinate implementation activities

Ideal Candidate

• Bachelor’s degree (or equivalent professional experience) in Life Sciences, Information Systems, Engineering, or related field.
• 5+ years of experience supporting IT systems or business processes in a biotech, pharmaceutical, or regulated life science environment.
• Direct hands-on experience implementing technical solutions (workflows, reports/dashboards, objects, security) and validating GxP computerized systems
• Experience managing validated applications in a regulated environment
• Experience defining data transfer processes and standards and/or data integration processes
• Strong understanding and working knowledge of GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, 210 and 211
• Ability to communicate ideas in both technical and user-friendly language
• Self-motivated and passionate about learning and adapting to new technology. Must be able to deal with ambiguity and work throug