Senior Director, Technical Operations

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November 20

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Loyal

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Healthcare Insurance • Artificial Intelligence • SaaS

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.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• 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.

🎯 Requirements

• PhD in Chemical Engineering or a closely related discipline, or equivalent industrial experience with deep technical expertise in process, analytical, and formulation development. • 12+ years of experience in biopharmaceutical CMC development and manufacturing, with increasing technical leadership responsibilities. • Proven experience leading early CMC development through successful product launch, including process validation and technology transfer. • Experience with small molecules and oral solid dosage forms strongly preferred. • Strong understanding of process and formulation design, scale-up, and control for both drug substance and drug product. • Demonstrated success guiding CDMOs and cross-functional CMC teams through complex technical challenges. • Comprehensive knowledge of global CMC regulatory expectations (FDA, EMA, ICH) and ability to translate technical findings into regulatory strategies. • Excellent technical judgment with the ability to synthesize complex data into clear, sound decisions. • Collaborative, pragmatic, and thrives in a fast-paced, matrixed, mission-driven biotech environment.

🏖️ 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