Loyal

Research Scientist

• Own and lead the end-to-end drug product development strategy, including pre-formulation, formulation development, scale-up, and clinical manufacturing.
• Serve as the technical lead for all drug product activities with CDMOs, including selection, oversight and troubleshooting
• Provide strategic guidance on raw material sourcing, manufacturability, product quality risk assessments, and lifecycle management considerations.
• Identify and proactively mitigate technical, regulatory, and supply risks; develop contingency strategies to ensure program continuity.
• Author, review, and approve drug product CMC sections for regulatory submissions (IND/CTA and amendments), and represent Drug Product CMC in regulatory agency interactions.
• Lead technical due diligence efforts, including CDMO evaluation, proposal review, data integrity assessments, and master batch record approval.
• Establish and implement robust experimental strategies, including design of experiments (DoE), to optimize formulation and process development.
• Mentor and provide scientific leadership to internal team members and consultants; elevate organizational capabilities in drug product development.
• Lead process readiness activities for Pre-Approval Inspections (PAIs), ensuring manufacturing processes, documentation, validation packages, and technology transfer records are inspection-ready and aligned with regulatory expectations

Senior Principal Scientist, Technical Operations

Vice President

• Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives.
• Own the end-to-end analytical and QC lifecycle from early development through commercialization, including commercial QC readiness, product release, stability programs, and post-approval lifecycle management.
• Serve as the accountable executive for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance.
• Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions.
• Lead the development, validation, transfer, and lifecycle management of analytical methods and control strategies, with immediate focus on small-molecule oral solid dosage products, while supporting additional modalities as the pipeline evolves.
• Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies.
• Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers.
• Provide executive oversight of deviations, investigations, OOS/OOT events, and CAPAs related to analytical and QC activities.
• Serve as a senior analytical subject-matter expert in interactions with FDA Center for Veterinary Medicine (CVM) and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections.
• Select, manage, and govern external analytical laboratories, CDMOs (as applicable), and other partners to ensure technical performance, compliance, and cost effectiveness.
• Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders.
• Establish operating models that balance internal capabilities with strategic outsourcing to support a growing and commercial portfolio.
• Manage resource planning, aligning analytical and QC investments with pipeline priorities and long-term business objectives.

VP, Quality Control – Analytical Development

People Operations

• The mission of this role is to mature & scale our people philosophy and execution, in partnership with our Founder/CEO and executive leadership team, to set up Loyal for success as we move towards commercial launch of our first longevity drug.
• Building systems to scale and reinforce high performance and culture standards.
• Hiring, leveling, performance management, compensation, equity, and feedback. Be the steward of Loyal’s culture in moments that matter most: rapid growth, conflict, failure, and change.
• Be a thought partner to leadership.
• Act as a people business partner to support team leaders in people management.
• Create feedback loops that surface problems quickly and enable course correction at both individual and organizational levels.
• Care deeply about the individual, without losing the organization: design policies and structures that both maximize Loyal’s probability of success and support our team individually.
• Own the full Loyal team member lifecycle: from recruiting and onboarding to development, performance, and exits.
• Operations: employment law, compliance, and risk handled well without over-bureaucracy.

Senior Principal Scientist, Technical Operations

VP, Quality Control – Analytical Development

VP of People