Advisor/Sr Advisor/Director – Manufacturing Science

Key Responsibilities

• Serve as Global Product Steward and subject matter expert for lyophilized, ADC and parenteral products, holding end-to-end technical accountability for process performance, product quality, and supply across all manufacturing sites.
• Advance lyophilization technology in commercial manufacturing.
• Maintain the product technical knowledge base and lifecycle strategy, including process history, critical material and supplier knowledge, a product technical risk register, and a roadmap for yield, robustness, capacity, and site-network improvements.
• Collaborate with product development and manufacturing site for technology transfer, scale-up, process performance qualification/validation, and comparability activities.
• Escalate significant technical, quality, safety, compliance, and supply risks to TS/MS management with risk assessments and mitigation plans.
• Own the commercial control strategy for lyophilization critical process parameters and critical quality attributes, and maintain process understanding through continued process verification, stability and batch trending, and global product assessment.
• Partner with Product Development to ensure manufacturability of new ADC and lyophilized products and provide commercial manufacturing feedback.
• Author and review technical sections of global regulatory submissions, post-approval changes, and responses to regulatory questions, and support inspection readiness.
• Lead process improvement and lifecycle management projects, including introduction of new lyophilization, filling, and containment technologies and qualification of vials, stoppers, and other critical materials.

Basic Qualifications

• A degree in a relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, or Chemistry with one of the following: PhD degree with 5 years of practical experience in parenteral, biologic, or antibody drug conjugate drug substance or drug product development and/or manufacturing, or Master's degree with 10 years of practical experience, or Bachelor's degree with 15 years of practical experience.
• Hands-on experience with lyophilization development or manufacturing (e.g., formulation and cycle development, scale-up, tech transfer, or commercial cycle support).
• Working knowledge of protein-based and ADC drug product formulation and aseptic fill/finish processes.
• Experience supporting GMP commercial manufacturing, including technology transfer, process validation, and/or deviation investigation and resolution.
• Qualified candidates must be legally authorized to be employed in the United States.

Additional Skills/Preferences

• Direct ADC drug product experience, including handling of cytotoxic or highly potent payloads and the stability and process sensitivities of conjugated antibodies.
• Background in lyophilized product development, including formulation and excipient selection, freeze-drying cycle design, and thermal characterization, and cycle scale-up.
• Analytical characterization of lyophilized biologics and ADCs.
• Experience with container closure and critical material qualification, including vial and stopper selection, container closure integrity, and the interaction of materials with processing equipment.
• Product stewardship experience, such as serving as technical owner or product lead for a commercial or late-stage product, authoring annual product reviews or technical risk assessments, and managing multi-site process harmonization.
• Demonstrated leadership, influence, and problem-solving skills, including the ability to interpret complex technical data, troubleshoot manufacturing issues, and clearly escalate risks and recommendations to management.
• Preparation, review, and response to global regulatory submissions (e.g., BLAs, NDAs, or equivalent), post-approval changes, and support of regulatory inspections.
• Working knowledge of statistical design of experiments and analysis, and of containment strategies and occupational exposure limits for potent compounds.
• Strong written and oral communication skills, with the ability to collaborate effectively across Development, Operations, Quality, EHS, and external manufacturing partners.