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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
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