Senior Director, Process Validation and Manufacturing Science and Technology
1 month ago
The Associate Director, Process Validation and Manufacturing Science Leadership will lead technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network.
Key Responsibilities:- Manage and influence internal and external cross-functional teams to set strategic direction for late-stage development activities, leading to process performance qualification, associated CMC requirements, and regulatory submissions.
- Manage and influence strategy for execution of process performance qualification (PPQ) and product life cycle, ensuring readiness and execution status for PPQ/CPV activities and deliverables.
- Generate PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.
- Implement consistent process qualification, process validation, and CPV strategies.
- Support the establishment of network strategies for drug substance/drug product manufacturing and testing.
- Be an effective change agent and champion for continuous improvement and technical innovation within the BSMO network.
- Collaborate with risk management and program management functions to articulate technical risks and develop/mitigate.
- Liaise with tech leads from other programs to build collective biopharmaceutical operations knowledge.
- Engage across industry forums to identify best practices and improvement opportunities.
- 8+ years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
- Master's or doctoral degree in a science or engineering field.
- Experience in process validation at commercial scale and bench scale.
- Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
- Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
- Advanced experience in a key technical leadership/management role in biologics process development, MSAT, and/or manufacturing.
- Previous leadership experience working in a highly matrixed environment.
- Experience with cGMP manufacturing, regulatory guidance, and health authority inspections.
- Experience authoring/reviewing CMC product submissions and post-approval changes.
- Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.
- Experience with operational excellence practices and root cause methodologies desirable.
- Ability to travel, domestically and internationally, up to 25%.
This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
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Seattle, Washington, United States Vertex Pharmaceuticals Full timeAs a key member of the Commercial Manufacturing and Supply Chain organization at Vertex Pharmaceuticals, the Associate Director, Process Validation, Manufacturing Science and Technology will play a crucial role in leading technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations network.The ideal candidate will have a...
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