Principal Engineer, Global Technology Transfer, Business Process Join to apply for the Principal Engineer, Global Technology Transfer, Business Process role at BioSpace

The information below covers the role requirements, expected candidate experience, and accompanying qualifications. Summary Principle Engineer – Global Technology Transfer, Business Process. Technology transfer is a pivotal component of a drug product’s lifecycle management as it transitions between early and late-stage development and into a commercial stage. Establishing and maintaining best practices and first principles for technology transfer is foundational to maintain consistency with our strategy. The global technology transfer business process focuses on ensuring speed, consistency, and right first-time technology transfers (TT) for internal and external development and commercial Drug Substance, Drug Product, Device, and Packaging/Labeling processes. Success is rooted in dedicated TT teams of experts in process, manufacturing, quality, regulatory, engineering, and project management, utilizing standardized BioMarin TT departmental playbooks, documentation, tools, and templates for phase-appropriate planning, process and facility knowledge consolidation, operational readiness, and risk management. The owner will: Lead cross-functional teams through the development and management of the technology transfer process, policies, operational standards, and best practices over the product’s lifecycle. Incorporate phase-appropriate requirements/expectations for technology transfers. Define and maintain roles and responsibilities among various functional teams. Form and lead a technology transfer forum to develop core processes, modules, timelines, tools, and templates, guiding cross-functional teams. Develop, manage, and optimize standardized technology transfer documentation and site-specific documentation including facility and equipment assessments, process comparisons, and FMEAs. Develop adherence to plan and monitoring metrics for policies and standards. Provide technical and strategic leadership for new product introduction and process validation. Support complex technology transfers across drug substances, products, devices, and packaging. Establish governance structures in partnership with site operations. Contribute to overall strategy as a member of the GPS leadership team. Maintain current knowledge of industry standards and best practices. Represent the company during regulatory inspections and establish collaborative relationships across functions. Qualifications BA or BS in a technical discipline; advanced degree preferred. 16+ years in a GMP environment with expertise in technology transfer, validation, and quality activities. 10+ years in management or supervisory roles overseeing technical activities. Strong leadership, technical, management, and problem-solving skills. Experience participating in regulatory inspections and defending departmental functions. Familiarity with regulatory guidelines (FDA, MHRA, EMEA, JNDA, etc.). Exemplary technical writing skills. Additional Information This is an individual contributor role with no direct supervisory responsibilities. The position involves interaction across multiple levels and departments, including regulatory, manufacturing, quality, and more. BioMarin is committed to diversity and equal opportunity employment.

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