Director, Process Chemistry and Drug Product

Society for Conservation Biology; Brisbane (CA); Remote; USD 215,000 - 230,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Process Chemistry and Drug Product to oversee the development and manufacturing of pediatric oncology treatments. This role involves managing CMO relationships, ensuring compliance with regulatory standards, and leading process improvements. The ideal candidate will have extensive experience in API development and project management, with a Ph.D. or equivalent experience. Flexibility for remote work is offered, along with a competitive salary range.

Qualifications

• 10+ years of experience for Ph.D. holders or 12+ years for MS/BS.
• Expertise in small molecule API development and ADC chemistry.

Responsibilities

• Manage CMO relationships for small molecule manufacturing.
• Lead development and transfer of APIs and ADC bioconjugation processes.
• Oversee formulation development ensuring cGMP compliance.

Skills

Project Management

Collaboration

Education

Ph.D. in relevant field

MS/BS

Job description

Director, Process Chemistry and Drug Product

Employer: Day One Biopharmaceuticals | Location: Brisbane, California, US | Salary: Competitive | Closing date: May 14, 2025

Sector: Consultancy/Private Sector | Field: Conservation science | Discipline: Project Management | Job Level: Senior | Employment Type: Full time

Job Description

DIRECTOR, PROCESS CHEMISTRY AND DRUG PRODUCT

Day One Biopharmaceuticals is an emerging, mission-driven drug development company focused on pediatric oncology treatments. For more information, visit our website.

Position Summary

The Director will oversee development, scale-up, manufacturing, and transfer of small molecule APIs, ADC payload-linkers, and drug products, managing global CMO relationships and ensuring compliance with regulatory standards.

Essential Duties and Responsibilities

1. Manage CMO relationships for small molecule manufacturing and ADC bioconjugation, including batch execution and process improvements.
2. Lead development, optimization, and transfer of APIs, payloads, linkers, and ADC bioconjugation processes.
3. Author and review regulatory submissions, including process descriptions and control strategies.
4. Oversee formulation development and manufacturing of biopharmaceutical drug products, ensuring cGMP compliance.
5. Manage CMOs to ensure successful manufacturing campaigns and timely resolution of issues.
6. Participate in cross-functional teams, develop manufacturing strategies, and drive continuous improvement initiatives.
7. Collaborate with analytical, regulatory, quality, and supply chain teams to ensure product quality and compliance.

Qualifications

• Ph.D. in relevant field with 10+ years of experience or MS/BS with 12+ years.
• Expertise in small molecule API development, ADC chemistry, and parenteral drug formulation.
• Experience managing external CMOs/CDMOs and familiarity with cGMP and regulatory standards.
• Strong project management and collaboration skills.

Preferred Qualifications

• Experience with lyophilization, impurity profiling, and late-phase validation.

Additional Information

This role offers flexibility for remote work, with occasional travel (~10%). The salary range is $215,000 - $230,000, with benefits detailed at our website.

Day One is an equal opportunity employer, committed to diversity and inclusion.