Subject matter expert in protein purification, drug product formulation, fill, and lyophilization.
Manage and/or support knowledge management (including product, process, and analytical)
Manage and/or support process, analytical, microbial control strategy development and implementation, and risk assessment and mitigation.
Build and support long term business relationships with key Contract Manufacturing Organizations in support of flexible and efficient supply chains.
Manage and/or support technical transfer and technical/COGS improvement projects. Ensure effective stakeholder engagement and ensure on-time and in-budget delivery.
Support regulatory CMC and registrational activities for clinical/commercial products as required, with a focus on ex-US.
Liaise with Quality/Supply Chain on product disposition and ensure continuous alignment with quality/supply chain systems requirements. Support technical investigations, deviations and CAPAs as required. Support and participate in site audits, as required.
Manage and/or support hiring and development of staff, as required.
Ensure CMO site operational readiness for manufacturing campaigns/process transfer/change controls/validations; including facilities, equipment, documentation, training.
Utilize strong operational excellence / lean principles, business acumen, quality-mindedness, and excellent communication skills to develop streamlined, efficient, and robust systems.

A minimum of 9 years of related experience with a Bachelor's degree; or 7 years and a Master's degree; or a PhD with 4 years experience in a relevant Life Science discipline or equivalent in work experience.
In-depth understanding of protein purification, characterization, drug product formulation, fill and lyophilization. Good understanding of protein expression, cell culture processing, and QC methods is a plus.
Strong prior operational experience preferably in a direct role in a GMP manufacturing environment, with interfaces to Supply Chain, Quality and Regulatory functions, with commensurate experience supporting internationally licensed products.
Direct experience managing contract development/manufacturing organizations (CDMOs), with focus on aseptic operations and commercial manufacturing, is preferred.
Must possess a thorough understanding of biotherapeutics manufacturing.
Demonstrated business and commercial focus with awareness of customer/patient-centric issues.
Experience working in a global business environment across multiple time zones.
Self-starter, possessing strong verbal and written communication skills.
Ability/willingness to travel globally for extended periods, based on business needs.

Senior Manager, Protein Sciences, Downstream

Key skills