Principal Engineer, Global Technology Transfer, Business Process

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Principle Engineer – Global Technology Transfer , Business Process SUMMARY Technology transfer is a pivotal component of a drug product ’s life cycle 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 is focused on ensuring speed, consistency, and right first-time technology transfers (TT) for internal and external development and commercial D rug Substance , D rug P roduct , Device, and Packaging/Labeling processes .

Success of technology transfers are rooted in and established through dedicated TT teams of subject matter experts in process, manufacturing, quality, regulatory, engineering, and project management that utilize standardized Bio Marin TT departmental playbooks, documentation, tools and templates for phase appropriate planning, process and facility knowledge consolidation, operational readiness, and risk management that ensure successful t echnology t ransfers over the product’s lifecycle .

Reporting to the Sr. Director of G lobal Process Services (GPS), within Technical Development and Services (TDS), the technology transfer business process owner will:

• Lead cross functional teams through the development and management of the technology transfer process, policies, operational standards, and best practices end to end, over the product’s lifecycle (starting materials, drug substance, drug product, labeling and packaging, device, etc . ) .

• Incorporate phase appropriate requirements/expectations for technology transfers.

• Define and maintain roles and responsibilities among the various functional teams.

• Form and lead a technology transfer forum where development of core processes, modules, timelines, tools, and templates are performed, as well as guide cross-functional technology transfer teams through the process.

• Develop, manage , and optimize standardized technology transfer documentation (e.g., site specific, protocols, re ports, risk assessments, etc.).

• Develop, manage, and optimize site specific documentation including, facility and equipment assessments, process comparisons, process FMEAs, tools, etc.

• Develop adherence to plan and monitoring metrics for the technology transfer policies and operational standards.

• Provide technical and strategic leadership through partnerships among sites, global functions, and third parties for new product introduction and process validation.

• Support complex drug substance , drug product , device , and packaging/labeling technology transfers.

• Establish and manage technology transfer governance structures in partnership with site operations supporting advice and decision-making processes.

• Provide standardized approach and executional excellence for techn ology transfers and process validation for drug substance , drug product , devices , and combination products at the Novato, Shanbally and Global External Operations (GEO) sites.

• Serve as a member of the GPS leadership team and contribute to the overall functional strategy, network strategy, and direction of the product .

• Influence l eadership on decisions related to technology transfer strategy that are critical to the success of the TOPS business objectives.

• Maintain current knowledge of industry standards on technology transfer and commercial device and combination product solutions for product development

• Standardize and publish global policies , best practices and standards across sites to streamline technology transfer activities , governance, and decision making.

• Partner with team members across all levels and…