R&D Systems Analyst

Summary

Join Apogee Therapeutics' growing IT Enterprise Applications team as an R&D System Analyst. You will support R&D functions by optimizing systems and business processes, managing change controls, and supporting computer system validation (CSV) activities in a GxP-regulated environment. This role involves working with applications and tools used in clinical trials and collaborating with IT and R&D stakeholders. You will play a key role in the lifecycle management of R&D systems like Veeva Vault. The position reports to the Associate Director, GxP R&D Systems. This is a fast-paced role requiring strong technical and communication skills, experience in a regulated environment, and a passion for learning and adapting to new technologies.

Requirements

• 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 through issues with agility without compromise to best practices and documentation
• Must have proven business and technology skills with success providing customer-oriented technology solutions
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 10-15%

Responsibilities

• 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
• 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
• 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
• 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

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve