Associate Director, Technical Operations

About the role

This position reports to the Senior Director, Technical Operations and is responsible for the development, execution, and ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development, ensuring test article and study drug are developed and manufactured on time, within budget & scope. This individual leads external manufacturing partners and collaborates closely with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to identify and mitigate CMC risks and achieve development, regulatory, and commercialization milestones.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I–III clinical development and commercial products.
• Lead the selection, qualification, governance, and performance management of CMOs, collaboration partners, and other external technical service providers, ensuring delivery against agreed scope, quality, timelines, and budget.
• Oversee chemical development of new drug candidates
• Review regulatory filings, specifications, change controls, and Master Batch records
• Provide technical oversight of CMOs responsible for developing, validating, transferring, and maintaining manufacturing and analytical methods for clinical and commercial production of APIs and finished dosage forms.
• Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP requirements and global regulatory expectations.
• Provide technical leadership and mentorship to colleagues and cross-functional project teams.
• Author/edit CMC sections of regulatory submissions as required
• Additional duties assigned as needed.

Requirements

• Bachelor’s degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered.
• 8 years of progressive cGMP related CMC drug development or manufacturing experience required.
• Must show demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Skills

• The ideal candidate will embody core values: Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Manufacturing experience with oral solid dosage forms.
• Advanced knowledge of process validation, technology transfer, manufacturing controls, and phase-appropriate cGMP requirements.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills.
• Excellent decision-making and collaboration skills with strong attention to detail.
• Ability to travel 10% domestically and internationally

Pay

Compensation range: $150,000 – $195,000 (based on level/experience).