Director, CMC Technical Operations

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

About the job

Protego Bio is a clinical-stage biotechnology company based in San Diego, California, focused on developing first-in-class small-molecule therapeutics that target protein misfolding diseases. By restoring protein stability and function through novel pharmacological chaperones, Protego aims to transform the treatment of rare and systemic diseases with significant unmet medical need.

Protego's lead program is being developed for AL amyloidosis and builds upon the clinically validated pharmacological chaperone approach pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, whose work led to the discovery and development of tafamidis for transthyretin amyloidosis (ATTR).

Primary Responsibilities:

Technical operations and clinical supply management

• Manage the flawless execution of CMC activities associated with the development and commercialization of company portfolio assets partnering with the clinical operations team
• Global distribution, logistics, and inventory oversight - oversee initiation of global shipment, import/export requirements, depot and site-level inventory, expiry/stability monitoring, and temperature-excursion investigations, ensuring the correct drug product is in the right place, in compliant condition, at the right time.
• Drive alignment across Technical Operations, Clinical Operations, Quality Assurance, and Regulatory teams to clarify and communicate project priorities, progress, challenges, and resolution of issues .
• Provide alliance management oversight of service providers (CDMOs) to ensure work is delivered within contracted scope, schedule, and budget.
• Anticipate end-to-end supply forecasting and planning, develop study-level clinical trial material forecasts and integrated supply plans aligned with study execution strategy, including country-level and overall timelines;responsible for translating manufacturing (DS, DP, labeling, expiry) timelines and release plans into a robust clinical supply strategy .
• Provide IRT/IWRS system ownership, partner with clinical CRO on specification, user acceptance testing (UAT), and ongoing oversight of the Interactive Response Technology (IRT) system.
• Risk management and cross-functional coordination, identify supply chain risks (delays, shortages, temperature excursions, expiry) and lead contingency planning, partnering with Clinical Operations, Regulatory and Quality to keep CTM supply aligned with study execution and to maintain GxP/GDP compliance and TMF-ready documentation .
• Bridge CMC core teams and sub-teams to ensure coordination of technical activities and timelines with all aspects of the organization.

Cross Functional Collaboration

• Partner with the rest of the CMC team, Clinical Ops, Quality, Analytical Development, Clinical, Nonclinical, and Program Management to align development plans, timelines, and risk-mitigation strategies with global CMC regulatory expectations.
• Provide input on CMC and clinical supply chain decisions.
• Influence and align with the CSO and executive leadership on CMC matters that have material program or financial impact.
• Contirubute to a vendor and partner ecosystem that gives Protego the leverage of a larger organization while preserving the speed of a small one.

Required Education, Experience, Skills, And Abilities

• Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
• 5+ years of progressive technical operations and clinical supply chain experience with a strong and demonstrated focus on CMC for small molecules in biotech or pharmaceutical environments.
• Demonstrated working knowledge of global CMC regulatory and operational frameworks.
• Demonstrated experience in small, lean biotech environments, ideally including a program that transitioned from early clinical development through pivotal trial and toward registration.
• Strong technical fluency across small molecule drug substance and drug product development, analytical sciences, process validation, and control strategy.
• Experience managing CDMOs and external regulatory/CMC consultants as the operational backbone of a virtual or hybrid CMC organization.

Preferred Qualifications

• Demonstrated successful management of a global clinical trial supply chain
• Ability to plan for and manage simultaneous priorities and changing deadlines in a fast-paced environment
• Excellent oral and written communication skills
• Excellent leadership, communication, and problem-solving skills
• Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders
• Excellent communication and presentation skills to efficiently relay information to staff, project teams, executive leadership, and other key stakeholders
• Proven ability to work independently and be self-motivated

Salary: $200,000 - $240,000 per year

In addition to a competitive base salary, we offer stock options, and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

Job Type: Full-time

• Incentive stock option plan
• 401k plan with employer contribution
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness)
• Paid Time Off
• Company Paid Holidays

Schedule

• Monday to Friday

Work Authorization

• United States (Required)

Additional Compensation

• Annual targeted bonus %

Work Location:

• Hybrid preferred in San Diego office with ability to travel up to 25% for meetings or site visits as required.

Equal Opportunity Employer

Protego Biopharma is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.