Job SummaryThe 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.
Core 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.
Required Qualifications- 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
- Experience with protein products expressed in E. coli is highly desirable
- 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
Work Schedule and Location- This role is remote within the US and requires availability to work US Eastern Time Zone.
- Ability to travel domestically and internationally as needed to support oversight and management of CDMOs.
Savara provides Comprehensive Benefits including:- Medical, dental, and vision coverage
- Flexible Spending Account for health care and dependent care expenses and Health Savings Account
- Paid time off and paid holidays, including Dec 24-Jan 1
- Paid parental leave
- 401(k) with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
- Other supplemental insurance programs
Savara's compensation for this role will include a base salary, bonus, and equity. The base salary range for this role is $185,000 to $215,000.
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