Director, Drug Product Technical Operations

Day One Biopharmaceuticals; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Drug Product Technical Operations to provide strategic leadership in small molecule development and manufacturing. This role involves overseeing drug product manufacturing, ensuring compliance with GMP standards, and leading technology transfer activities. The ideal candidate will have extensive experience in drug formulation, process development, and strong leadership skills. The position offers remote work flexibility with occasional travel.

Qualifications

• 10+ years in drug product formulation and manufacturing.
• Expertise in oral solid dosage forms and technology transfer.

Responsibilities

• Provide technical leadership in drug product development and manufacturing.
• Oversee process characterization and optimization for non-sterile formulations.
• Manage CMO oversight and ensure compliance with regulatory standards.

Skills

Leadership

Project Management

Process Development

GMP Knowledge

Education

Ph.D. in Pharmaceutical Sciences

M.S. in Chemical Engineering

B.S. in Biochemistry

Job description

Director, Drug Product Technical Operations

Get AI-powered advice on this job and more exclusive features.

Position Summary

The Director, Drug Product Technical Operations will provide strategic leadership and technical oversight for clinical and commercial small molecule development and manufacturing within the global CMO/CDMO network. This role involves ensuring seamless drug product manufacturing across the oral solid dose portfolio, working closely with internal teams such as CMC, regulatory, quality, and supply chain.

As a key technical leader, the Director will drive lifecycle strategies, continuous improvement initiatives, technology transfers, and process validation to support both clinical and commercial assets. The role also includes authoring regulatory documentation and ensuring compliance with GMP standards.

This position reports to the Vice President of CMC Technical Operations and offers the flexibility of remote work, with occasional domestic and international travel (~10%).

Essential Duties and Responsibilities

1. Drug Product Development, Process Optimization & Manufacturing
2. Provide technical leadership in formulation, development, manufacturing, labeling, and packaging of small molecule drug products.
3. Lead operations for clinical and commercial solid oral dose products, optimizing process control and quality.
4. Oversee process characterization and optimization for non-sterile formulations like tablets, capsules, and suspensions, including intermediates such as spray drying, hot melt extrusion, blending, tableting, and film coating.
5. Develop risk-based process control strategies to ensure robustness, manufacturability, scalability, and compliance.
6. Design and optimize formulations for clinical trials, ensuring stability, bioavailability, and manufacturability; define critical quality attributes and process parameters.
7. Lead process scale-up and validation efforts.
8. Collaborate with internal teams to support lifecycle management, process improvements, cost efficiencies, and technology adoption.

CMO/CDMO Oversight & Technology Transfer

1. Develop risk-based oversight strategies for CMOs, considering product stage and complexity.
2. Manage process and product monitoring plans, performance metrics, and compliance with quality systems.
3. Handle deviations, investigations, and change controls with CMOs.
4. Lead technology transfer activities, ensuring smooth scale-up and validation.

Operational & Regulatory Compliance

1. Support GMP manufacturing activities, including batch reviews and deviation management.
2. Review and author CMC sections for regulatory submissions, ensuring compliance with FDA, EMA, ICH standards.
3. Manage manufacturing budgets, promoting cost efficiency and operational excellence.
4. Implement continuous improvement initiatives.
5. Work cross-functionally to align operations with organizational goals.

Qualifications

• Ph.D., M.S., or B.S. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related field.
• 10+ years in drug product formulation, process development, and manufacturing.
• Expertise in oral solid dosage forms.
• Experience in technology transfer, process validation, and product launches.
• Deep knowledge of GMP, regulatory standards, and QbD principles.
• Experience managing CMOs and global supply chains.
• Strong leadership and project management skills.
• Experience in fast-paced, small company environments.

The preceding description indicates the general nature and level of work performed by employees in this role.