Sr Director, Technical Operations
$255,000–$357,000 year
HybridIrvine, California, United States
Job Summary
Define and lead end-to-end drug product manufacturing strategy from late phase clinical through commercial stages, ensuring scalability of processes, supply chain, and CMO network to support commercialization growth. Provide senior oversight of CDMO relationships, including performance management, capacity planning, and long-term partnership strategy, while establishing governance models for accountability across external partners. Lead resolution of critical manufacturing issues, including deviations, investigations, and high-risk events, serving as the escalation point for complex technical and operational challenges. Partner cross-functionally with Pharmaceutical Sciences, Analytical Development, Supply Chain, Regulatory, and Quality to align CMC strategy and execution, ensuring readiness for regulatory submissions and inspections. Manage Person-in-Plant coverage to provide adequate oversight for manufacturing activities, develop and manage the budget for CMC programs, and collaborate with Finance to address budget variances. Some travel may be required up to 30%.
Required Qualifications
- B.S. /M.S./Ph.D. in one of the relevant Engineering or Science fields
- Strong understanding of technical/scientific challenges as those apply to the production processes used in the manufacture of Sterile products and the subsequent packaging of those products
- 15+ years of progressive responsibility in Technical Operations and/or manufacturing support in pharmaceutical manufacturing
- Doctorate degrees require a minimum of 10 years total experience
- Must have strong understanding of project management systems and tools
- Must have strong business and financial skills
- Established track record with evidence of excellent people management experience
- Problem solving skills
- Collaborative skills
- Leadership skills
- Communication skills
- Strategic Leadership - Translates corporate vision and strategy into departmental goals and objectives
- Adjusts plans and tactics to meet changing departmental priorities and circumstances
- Utilizes market data
- High-energy
- Learning orientation
- Ability to work in a fast-paced environment
- Strong communication and change management skills
- Ability to build strong relationships both vertically and horizontally
- Proven ability to escalate difficult issues and make tough decisions
- Empowering Others - Fosters empowerment by aligning authority with accountability, developing leaders' decision-making capability, and creating systems that support performance and growth
- Emotional Intelligence - Foster trust and psychological safety, navigating complex interpersonal dynamics with compassion and accountability, and adapting leadership style to support others while maintaining composure under pressure
- Grows Capacity - Builds organizational capacity by developing talent systems, coaching cultures, and strategic partnerships that grow leadership strength and prepare the next generation of leaders
- Business Acumen - Demonstrates strong business acumen by anticipating market dynamics and using financial and strategic insight to guide investments, manage risk, and align priorities with long-term organizational value
- Innovative Mindset and Action - Demonstrates an innovative mindset by championing new ideas, investing in enabling systems and partnerships, and translating innovation into sustainable growth and organizational resilience
- Some travel may be required – up to 30%
- The position will be based in our beautiful Irvine office
- We provide a hybrid work environment
- Remote work is an option for the right candidate
Desired Qualifications
- Preferable experience in all the following areas: Sterile ophthalmic dosage forms, Solid Oral Dose and Packaging and Topical Dermal formulations
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