Director, Drug Substance (remote US)

ARAVAS INC• PA, US, PA

7h•$185,000 - $215,000•Remote

About The Position

The Director, Drug Substance (DS) reports to the Head of Drug Substance, GTO function. The Director DS utilizes their strong background in biologics process development and commercialization to work closely with internal stakeholders and external CDMO(s) to ensure successful oversight of drug substance process development, technology transfer, and manufacturing activities supporting Savara’s product pipeline through commercial readiness.

Requirements

PhD or Master’s degree in life sciences, biochemistry, chemical engineering, or a related discipline
10+ years of technical experience in process development, manufacturing, process characterization and process validation for biologics
Demonstrated experience leading technology transfer of biologics manufacturing processes to CDMOs and providing ongoing manufacturing oversight
Well-developed understanding of all aspects of drug development, including early- and late-stage CMC, regulatory submissions, and commercial readiness
Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives
Strong ability to handle complex, fast-moving situations, triage technical issues, and resolve conflicts with internal and external stakeholders
Excellent verbal and written communication skills, including technical report writing and the ability to distill complex CMC information into clear, actionable plans

Nice To Haves

Experience with protein products expressed in E. coli is highly desirable

Responsibilities

Provide technical guidance to inform drug substance process development, manufacturing, and commercialization decisions
Lead technology transfer of drug substance manufacturing processes to CDMOs and oversee CDMO process development and manufacturing activities to ensure on-time delivery of material
Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements
Oversee manufacturing campaigns at CDMOs, including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
Drive process lifecycle management improvements, including process characterization, robustness studies, scale-up, and process performance qualification activities
Author and review technical reports, process descriptions, and CMC sections for regulatory submissions
Partner closely with internal stakeholders (Drug Product, Analytical Development, Quality, Regulatory, Supply Chain, Program Management) and CDMO counterparts to ensure seamless integration of drug substance activities into overall program execution
Identify drug substance technical and operational risks and partner with cross-functional teams to develop and execute mitigation strategies
Communicate drug substance program priorities, risks, and key decisions clearly and proactively to leadership
Periodically embed at CDMO sites to oversee key manufacturing campaigns and resolve technical issues in real time
Other duties and projects as assigned.