Senior Director, Analytical Development

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $230k - $280k / year

⏰ Full Time

🟠 Senior

👔 Director

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Loyal

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

📋 Description

• Set and execute the global analytical development and quality control strategy aligned with Loyal’s corporate and CMC objectives. • Serve as the accountable executive for GMP analytical operations, ensuring inspection-ready systems, data integrity, PAI readiness at Loyal and CDMOs, and sustained regulatory compliance. • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions. • Lead development, validation, transfer, and lifecycle management of analytical methods and control strategies for small-molecule oral solid dosage products and additional modalities. • Own dissolution strategy, including discriminating method development, validation, and dissolution data packages for CVM submissions. • Author and review analytical content of NADA CMC technical sections, including method validation summaries, specification justifications, stability narratives, and deficiency responses. • Lead drug substance analytical strategy, including method development and validation, specifications, impurity control, stability programs, reference standards, and testing at API manufacturers and starting material suppliers. • Own stability strategy, including protocol design, statistical evaluation, shelf-life assignment, and trending. • 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 senior analytical subject-matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including submissions, responses, and inspections. • Select, manage, and govern external analytical laboratories, CDMOs, and other partners. • Build, scale, and lead a high-performing QC and analytical development organization, including hiring, mentoring, and developing senior technical leaders. • Establish operating models balancing internal capabilities with strategic outsourcing. • Manage resource and budget planning aligned with pipeline priorities and long-term business objectives.

🎯 Requirements

• Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline. • 18+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small-molecule oral solid dosage forms. • Demonstrated experience spanning early development, clinical programs, commercial launch, and post-approval lifecycle management. • Proven success building and leading analytical and/or QC organizations, including hiring, mentoring, and developing senior technical leaders. • Extensive experience with analytical method development, phase-appropriate validation, method transfer, and GMP QC operations. • Direct experience interacting with FDA on regulatory submissions, responses, meetings, and inspections, with working knowledge of ICH guidelines. • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution. • Track record of leading the analytical and control-strategy content of NADA/NDA CMC sections through approval, including deficiency responses and pre-approval inspections. • Strategic mindset with the ability to translate scientific and regulatory complexity into clear, actionable business recommendations. • Comfortable operating in a fast-paced, growth-stage environment, balancing hands-on technical leadership with executive-level decision-making. • Excellent communication and influencing skills, with the ability to engage credibly with executive leadership, regulators, and external partners. • Preferred: Knowledge of animal health regulatory requirements, including FDA CVM and VICH guidelines.

🏖️ Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member • Competitive salary • Company equity options grant for new hires

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