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Senior Director, Technical Operations

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Loyal

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

230000.00 - 280000.00 USD / Year

Job Description:

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.

Job Responsibility:

  • 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

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
What we offer:
  • 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

Additional Information:

Job Posted:
December 10, 2025

Employment Type:
Fulltime
Work Type:
Remote work
Job Link Share:

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