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Senior Director, Technical Operations
Senior Director, Technical OperationsLoyal • Cleveland, OH, US
Senior Director, Technical Operations

Senior Director, Technical Operations

Loyal • Cleveland, OH, US
7 days ago
Job type
  • Full-time
Job description

Senior Director, Technical Operations

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We've already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the Role

We're seeking an experienced Senior Director, Technical Operations to provide technical leadership across all CMC disciplines as we advance our programs from early development through commercialization including preparations for upcoming product launch.

This role serves as a cornerstone of our Technical Operations organization, ensuring connectivity, scientific rigor, and technical excellence across process, analytical, and formulation development, manufacturing, and supply.

The ideal candidate holds a PhD in Chemical Engineering or a related discipline, brings deep expertise in small molecule and oral solid dosage development, has led early-stage CMC activities, and possesses a proven track record of launching commercial products.

You'll integrate and drive the technical aspects of CMC strategy ensuring robust science, risk-based decision-making, and manufacturing readiness that support Loyal's mission and future launches. This role reports to the Chief Technical Operations Officer and works closely with CMC functional leads and executive leadership.

Your Daily Work Will Include

  • 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.

About You

  • 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.
  • Nice to Have

  • Experience building or scaling Technical Operations capabilities during the transition from development to commercialization.
  • Familiarity with lifecycle management, continued process verification, and commercial supply optimization.
  • Experience with veterinary or animal health manufacturing.
  • Passion for Loyal's mission to bring science-driven longevity therapeutics to dogs.
  • Salary range : $230,000 - $280,000

    Loyal 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
  • Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.

    Our Values

    Lean into Moonshots

    We don't settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.

    Opportunity is at the Intersection

    We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

    Expertise without Ego

    Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.

    Learning by Doing

    Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.

    Lead with Context

    We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.

    Empathy and Respect for All Life

    Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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