Loyal

Operations

• Provide technical leadership and integration across process, analytical, and formulation development, ensuring scientific rigor, data integrity, and seamless progression from early development through commercialization.
• Drive technical connectivity among CMC functions to maintain alignment, consistency, and robust science across all development stages.
• Lead technical risk assessment, mitigation, and decision-making, ensuring issues are identified, analyzed, and resolved through data-driven approaches.
• Partner with CMC functional leads and CDMOs to develop and refine scalable, robust, and reproducible processes for drug substance and oral solid dosage drug and finished products.
• Oversee technical readiness for key milestones including IND/IMPD, NDA/MAA, and commercial launch.
• Lead or contribute to CMC sections of regulatory submissions and represent Loyal in technical discussions with regulatory authorities.
• Collaborate closely with Quality, Regulatory, Clinical, and Commercial functions to ensure technical and operational alignment.
• Mentor and guide internal scientists and external partners to uphold a culture of technical excellence and accountability.

Senior Director, Technical Operations

Vice President

• Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply.
• Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites.
• Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes.
• Drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability.
• Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations.
• Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container–closure documentation.
• Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings.
• Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses.
• Partner with Quality to support technical investigations, root-cause analyses, and CAPA development.
• Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization.
• Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity.
• Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations.

VP, Manufacturing

QA Engineer

• Participate in a rigorous quality control program for Loyal’s clinical team and, where appropriate, collaborating with operational quality to integrate processes within the company quality system.&nbsp;
• Site visits to clinical trial sites (vet clinics) with clinical research associates (CRAs) to ensure procedural quality at the data collection sourceAssist in maintaining and organizing quality management system (QMS) documentation, including SOPs, CAPAs, and training records. Provide/support GCP guidance on questions arising from day to day clinical trial activities. Support clinical teams with quality-related questions, document requests, and system access.&nbsp;
• Identifying discrepancies and inconsistencies in data collection and, if necessary, providing remediation or training to the clinical operations team.
• Working closely with CRAs to standardize data collection methods and quality processes from site initiation through study close out.&nbsp;
• Utilize guidance documents and standards to interpret for guidance, ensuring quality and compliance to regulations.
• Support preparation for internal and external audits, including vendor and site audits.
• Help track and follow up on audit findings, deviations, and corrective/preventive actions (CAPAs).
• Assist in development of risk based, efficient audit plans at the study and site level.
• Partner with clinical team for risk identification, management, and mitigation activities.
• Oversight of deviation root cause analysis and CAPA development for pre-clinical and clinical studies.
• Participate in document control and review processes to ensure version control and compliance with GCP standards.
• Operating within electronic data capture systems and study drug inventory management systems (such as IWRS) to navigate large numbers of study subjects and ensure consistency and management of data across study sites.
• Performing user acceptance testing of electronic data capture builds specific for each clinical study.
• Own inspection readiness programs pertaining to pre-clinical and clinical studies
• Implementation of quality plans.
• Help develop and distribute training materials related to GCP, SOPs, and quality systems.
• Maintain quality metrics dashboards and assist with reporting to management.
• Stay informed about changes in regulations and quality best practices in clinical research.

Clinical QA Specialist II

Manager

• Provide quality oversight for analytical method development, qualification, validation, and transfer in support of veterinary drug substance and drug product programs.
• Review and approve analytical study protocols, validation reports, method transfer packages, and specifications.
• Ensure that analytical testing, release, and stability studies are executed under GMP/GLP conditions and in compliance with FDA and ICH/VICH guidelines.
• Partner with Analytical Development, QC, and Manufacturing to ensure accuracy, reliability, and consistency of analytical data.
• Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations.
• Ensure analytical activities comply with FDA-CVM, ICH, and VICH quality and data integrity requirements.
• Provide quality input for analytical sections of CMC documentation (e.g., INAD, NADA, VMF, and stability summaries).
• Participate in the preparation and review of regulatory submissions and responses to health authority questions.
• Support internal and external audits of analytical laboratories, contract testing organizations (CTOs), and contract manufacturing organizations (CMOs).
• Lead or assist in investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure.
• Author, review, and approve SOPs, technical documents, and quality records associated with analytical testing, method lifecycle, and data management.
• Maintain inspection readiness and ensure compliance of analytical documentation with company policies and regulatory standards.
• Support implementation and continuous improvement of the Quality Management System (QMS) related to CMC and analytical operations. Contribute to risk assessments for analytical methods, materials, and laboratory processes.

CMC Quality Manager, Analytical

• Lead the design and execution of the Clinical Quality Assurance strategy to ensure GCP compliance across all studies.
• Oversee and manage the clinical audit program, including investigator site audits, vendor audits, and internal process audits. All sites that are to be used for GLP/GCP work should be audited prior to conducting regulated work. This includes development of GLP and GCP facility audit documents.
• Develop, implement, and maintain policies, SOPs, and training programs to support compliance with global regulations (FDA, EMA, VICH-GCP, etc.).
• Partner with Clinical Operations, Regulatory, and other cross-functional teams to proactively identify and mitigate quality and compliance risks.
• Provide quality oversight of vendors and CROs to ensure adherence to contractual and regulatory obligations.
• Support clinical trial inspections (FDA, EMA, etc.) and lead preparation and response activities.
• Analyze audit trends and inspection findings to develop continuous improvement initiatives.
• Serve as the company’s subject matter expert (SME) on GCP-related quality and compliance matters.
• Review all protocols, data and reports being generated under GLP/GCP. This includes data collection & interpretation. Prepare quality summaries as required.
• Manage and respond to adverse events (with clin ops) for drug products in the clinic and beyond.
• Lead, mentor, and develop a team of quality professionals.
• Help with training new regulatory hires or contractors as appropriate.
• Building a Quality Assurance Unit process and team as Loyal grows and requires expansive quality assurance infrastructure.
• Prepare for Quality aspects of Global expansion.
• Develop, implement, and manage systems to ensure consistency and quality across all Loyal teams. Examples: Research Ops/Dog Ops QA: Standard checklists/docs for study design, study startup, data review, study closeout, and final reports. People Ops QA: Standard checklist for new employees (science-based section, ops-based section).
• Supporting commercial recalls, adverse events, customer complaints.
• Being the face of the company for Clinical Quality matters when interfacing with regulatory authorities.

Director of Clinical QA

Software Engineer

• Lead packaging process development, scale-up, and optimization for OSD drug products.
• Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations.
• Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements.
• Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness.
• Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs.
• Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity.
• Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries.
• Support or participate in PAIs and other regulatory interactions related to packaging.
• Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations.
• Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs.
• Drive continuous improvement across packaging operations, materials, and systems.
• Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development to ensure packaging readiness across all development and commercial stages.

Director – Packaging Engineering

• Maintain, monitor, and continuously improve the company’s eQMS in alignment with GxP (GCP, GLP, GMP) and ISO quality principles.
• Ensure eQMS documentation (e.g., SOPs, forms, work instructions, policies) is current, compliant, and effectively implemented across departments.
• Oversee document control processes, including drafting, reviewing, approving, and archiving quality documents.
• Lead periodic reviews and revisions of quality documents to ensure ongoing compliance and operational relevance.
• Identify gaps or new operational areas requiring formalized procedures; determine when new SOPs or updates are needed.
• Author, review, and approve SOPs in collaboration with functional area leaders.
• Ensure SOPs are clear, practical, and aligned with applicable regulations and internal best practices.
• Manage the SOP lifecycle, including version control, obsolescence, and communication of updates.
• Administer the company’s training management system, ensuring all staff receive and complete required training on time.
• Develop and implement training programs for onboarding, GxP, SOPs, and compliance topics.
• Track and report training completion metrics and maintain accurate training records.
• Collaborate with department heads to identify training needs and continuous improvement opportunities.
• Support internal and external audits by ensuring readiness and compliance across documentation and processes.
• Coordinate corrective and preventive actions (CAPA) and ensure timely follow-up and closure.
• Monitor quality metrics and generate compliance reports for management review.
• Promote a culture of quality, integrity, and continuous improvement across the organization.

Quality Assurance Compliance Officer

Financial Planning and Analysis

• Partner with the CEO and executive team to define and execute the company’s financial strategy aligned with organizational goals.
• Advise on strategic initiatives such as fundraising, capital allocation, pricing strategy, and market expansion.
• Provide thought partnership to the CEO around financial storytelling for the board and investors.
• Prepare financial materials for board meetings, investors, and fundraising efforts.
• Bring clarity to a complex financial model with multiple scenarios to provide an elegant picture of our finances to the board.
• Lead due diligence, scenario modeling, and strategic communication with investors and lenders.
• Partner with legal and external advisors to manage cap table, equity, and financing structures.
• Advise on future roadmap of the Finance & Accounting functions including prioritization of when to hire which roles, opportunities to automate or streamline financial workflows, or suggestions around systems to support financial reporting, forecasting, and variance analysis.
• Support internal Finance team and outsourced Accounting firms on compliance with GAAP, tax regulations, and other relevant financial requirements.

Fractional Chief Financial Officer

Compliance

• Lead Loyal’s CMC regulatory strategy, and lead company to a complete CMC dossier for our three drug products, starting with LOY-002.
• Working closely with CMC team to ensure phase-appropriate data to support successful regulatory submissions, and benefits/drawbacks of certain formulation decisions.
• Preparing technical sections and other regulatory documents for submission, including the review of protocols and reports to ensure compliance with regulations.
• Contributing to regulatory plans, strategies, and risk mitigation across the portfolio.
• Offering regulatory advice to cross-functional teams, leading the drafting of submission responses to regulatory queries, and collaborating with CMC and Quality departments for Scale-up and Post-Approval Changes.

Head of Regulatory CMC

• Strategic oversight of all drug program manufacturing and fulfillment from discovery to commercialization.
• Risk management and contingency planning, particularly for low-likelihood but high-impact adverse outcomes.
• Technical, day-to-day oversight of analytical, drug substance, and drug formulation functions.
• Represent Loyal with external CDMO partners and ensure seamless transition from R&D to commercialization.
• Ensure facilities, documentation, and operations are in a constant state of inspection readiness and in compliance with national & local regulatory requirements.
• Design and scale the organizational structure for Loyal’s technical manufacturing operations.
• Build and sustain a high-performing culture of efficient execution, ethics, truth seeking, and continuous improvement.