Associate Director, Process Validation, Manufacturing Science and Technology

6 days ago

Seattle, Washington, United States Vertex Pharmaceuticals Full time
Job Description

The Associate Director, Process Validation, Manufacturing Science and Technology (MSAT) role is a key leadership position within the Commercial Manufacturing and Supply Chain (CMSC) organization at Vertex Pharmaceuticals. This position will be responsible for leading technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network.

The role, based at our Seattle or Boston site, will partner with cross-functional teams internally and externally to ensure project deliverables supporting regulatory milestones are met and clinical and commercial supply to our patients is uninterrupted.

Key Responsibilities:
  • Manage and influence internal and external cross-functional teams, setting 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. Manages, tracks and reports on readiness/execution status for PPQ / CPV activities and deliverables.
  • Generates 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 / manage mitigations.
  • Liaise with tech leads from other programs to build collective biopharmaceutical operations knowledge.
  • Engage across industry forums to identify best practices and improvement opportunities.
Minimal Requirements:
  • 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.
  • Experienced 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%.
Pay Range:

$163,040 - $244,560

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

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. Actual base salary pay will be based on a number of factors, including skill

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