Director, CMC Tech Ops - Global Clinical Supply (Hybrid)

Protego Biopharma, Inc.; San Diego (CA); Hybrid; USD 200,000 - 240,000; Full time

Benefits offered by this job

Incentive stock option plan

401k plan with employer contribution

Dental and vision insurance

HSA, FSA, and supplemental plans

Paid Time Off

Company Paid Holidays

Job summary

Protego Biopharma, Inc. is seeking a senior technical operations professional to manage clinical supply chains and CMC activities for small-molecule programs. You will coordinate with clinical operations and QA to ensure compliant, timely delivery across global sites.

The role emphasizes alliance management with CDMOs, end-to-end supply forecasting, regulatory alignment, and risk mitigation in a hybrid San Diego setting. Strong background in CMC for biotech is required.

Qualifications

• Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field; advanced degree strongly preferred.
• 5+ years of progressive technical operations and clinical supply chain experience with focus on CMC for small molecules in biotech/pharma.
• Knowledge of global CMC regulatory and operational frameworks.
• Experience in small, lean biotech environments and programs transitioning from early development to pivotal trials.
• Strong fluency across small molecule drug substance and product development, analytical sciences, process validation, and control strategy.
• Experience managing CDMOs and external regulatory/CMC consultants as backbone of a virtual/hybrid CMC organization.

Responsibilities

• Manage flawless execution of CMC activities for development and commercialization with clinical operations collaboration.
• Oversee global distribution, logistics, inventory, expiry/stability, and temperature-excursion investigations.
• Align Technical Operations, Clinical Operations, QA, and Regulatory on priorities and issue resolution.
• Provide alliance management oversight of CDMOs to ensure scope, schedule, and budget.
• Forecast study-level clinical supply and translate manufacturing timelines into robust supply plans.
• Own IRT/IWRS system with CRO coordination for testing and oversight.
• Identify supply chain risks and lead contingency planning to maintain GxP/GDP compliance.
• Bridge CMC core teams and sub-teams to coordinate activities and timelines.

Skills

Technical operations

Clinical supply chain

CDMOs management

GxP/GDP compliance

Supply forecasting

IRT/IWRS system ownership

Education

Bachelor's degree in Chemistry/Pharma

MS/PhD preferred

Job description

Protego Biopharma, Inc. is seeking a senior technical operations professional to manage clinical supply chains and CMC activities for small-molecule programs. You will coordinate with clinical operations and QA to ensure compliant, timely delivery across global sites.

The role emphasizes alliance management with CDMOs, end-to-end supply forecasting, regulatory alignment, and risk mitigation in a hybrid San Diego setting. Strong background in CMC for biotech is required.