Senior Director, Process Validation and Manufacturing Science and Technology
13 hours 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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