Associate Director, Drug Substance Manufacturing – Downstream Process
$175,000–$210,000 year
On-siteBrisbane, California, United States
Job Summary
Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing downstream activities. Lead investigations for technical deviations, root cause analyses, and CAPA implementation while supervising campaign readiness, change management, and process development discussions. Oversee technology transfer, PPQ readiness, and validations across CMO sites, authoring and reviewing validation protocols and technical documentation. Drive continuous improvement initiatives, standardize knowledge-sharing practices, and establish robust Continuous Process Verification protocols. Perform statistical analysis on campaign data to create process trends and control charts, developing lifecycle management strategies for commercial products. Author and review CMC sections for global regulatory submissions including BLA, MAA, and NDA, ensuring manufacturing strategies align with GMP and ICH expectations. Manage interactions with stakeholders across functions and communicate strategic plans to upper management.
Required Qualifications
- MS in relevant life sciences or engineering discipline
- minimum of 5 years of Pharmaceutical/Biotechnology industry experience
- BS with 8 years of experience
- experience in biologics drug substance downstream processes
- experience in technology transfer
- experience in cGMP manufacturing operations
- Extensive hands-on experience in downstream unit operations including chromatography
- Extensive hands-on experience in UF/DF
- Extensive hands-on experience in Viral clearance
- Experience in other protein purification methodologies
- Working knowledge of technology transfer
- Working knowledge of process validation
- routine management of GMP manufacturing
- Experience in managing US/international CDMOs
- Proven leadership and cross-functional management of CMC-related programs
- Track record of successfully driving and managing programs
- Track record of overcoming challenges
- Track record of managing risks
- Critical thinking and problem-solving skills
- ability to drive risk-based decision making
- Strong organizational and project management skills
- proficient use of MS Project
- proficient use of other tools
- Excellent communication and interpersonal skills
- ability to communicate strategic plans to upper management
- ability to summarize data
- ability to effectively manage interactions with stakeholders across functions
- ability to author CMC sections for global regulatory submissions
- ability to review CMC sections for global regulatory submissions
- ability to support responses to health authority questions related to manufacturing processes and controls
- ability to ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations
- ability to oversee all drug-substance downstream manufacturing activities at the CMO site
- ability to lead investigations for technical deviations
- ability to perform root cause analyses
- ability to implement CAPA
- ability to supervise campaign readiness
- ability to manage change management
- ability to manage process development discussions
- ability to lead internal technical meetings
- ability to manage timelines
- ability to manage supply impact
- ability to manage risks
- ability to manage budget
- ability to oversee technology transfer
- ability to oversee PPQ readiness
- ability to oversee validations across CMO sites
- ability to author validation protocols
- ability to review validation protocols
- ability to author validation reports
- ability to review validation reports
- ability to author technical documentation
- ability to review technical documentation
- ability to drive continuous improvement initiatives across downstream processes
- ability to drive standardization and knowledge-sharing practices across sites and the global network
- ability to perform statistical analysis on campaign data
- ability to create process trends
- ability to analyze process trends
- ability to create control charts
- ability to analyze control charts
- ability to develop near-term and long-term lifecycle management strategies
- ability to develop process improvement strategies
- ability to facilitate execution utilizing digital tools
- ability to establish and maintain robust process monitoring protocols
- ability to establish and maintain robust process monitoring procedures
- ability to establish and maintain Continuous Process Verification (CPV) protocols
- ability to establish and maintain Continuous Process Verification (CPV) procedures
- ability to support filing in new markets
- ability to conduct impact assessment to post-approval changes
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