Principal Engineer, Global Technology Transfer, Business Process

BioMarin Pharmaceutical; Novato (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

A leading biotechnology company seeks a Principle Engineer for Global Technology Transfer. This pivotal role involves leading cross-functional teams to ensure effective technology transfers and adherence to best practices throughout the product lifecycle. The successful candidate will have extensive experience in a GMP environment, strong leadership skills, and a technical background in engineering. Join BioMarin to make a meaningful impact on patients' lives.

Qualifications

• 16+ years in a GMP environment with knowledge of technology transfer.
• 10+ years in management/supervisory roles.
• Strong technical writing skills.

Responsibilities

• Lead cross-functional teams in technology transfer processes.
• Develop standardized documentation and adherence metrics.
• Collaborate with stakeholders and represent the company in inspections.

Skills

Leadership

Project Management

Problem-Solving

Education

BA or BS in a technical discipline (engineering preferred)

Advanced degree preferred

Job description

Principle Engineer – Global Technology Transfer, Business Process

SUMMARY

Technology transfer is a pivotal component of a drug product’s lifecycle management, transitioning between early and late-stage development into a commercial stage. Establishing and maintaining best practices and first principles for technology transfer is foundational to align with our strategy.

The global technology transfer business process ensures speed, consistency, and first-time-right 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 subject matter experts across process, manufacturing, quality, regulatory, engineering, and project management, utilizing standardized BioMarin TT departmental playbooks, documentation, tools, and templates for phase-appropriate planning, knowledge consolidation, operational readiness, and risk management.

Reporting to the Sr. Director of Global Process Services (GPS) within Technical Development and Services (TDS), the Technology Transfer Business Process Owner will:

1. Lead cross-functional teams in developing and managing the technology transfer process, policies, operational standards, and best practices throughout the product lifecycle.
2. Incorporate phase-appropriate requirements for technology transfers.
3. Define and maintain roles and responsibilities among functional teams.
4. Establish and lead a technology transfer forum for process development, timelines, tools, and templates, guiding cross-functional teams.
5. Develop, manage, and optimize standardized documentation, including site-specific protocols, reports, and risk assessments.
6. Manage site-specific documentation such as facility and equipment assessments, process comparisons, and FMEAs.
7. Develop adherence metrics for policies and standards.
8. Provide technical and strategic leadership for new product introduction and process validation through partnerships.
9. Support complex technology transfers for drug substances, products, devices, and packaging.
10. Establish governance structures supporting advice and decision-making.
11. Ensure standardized execution for technology transfers and validation at various sites.
12. Contribute to GPS leadership strategy and influence decisions critical to business objectives.

KEY RESPONSIBILITIES - Leadership

1. Maintain current knowledge of industry standards.
2. Standardize and publish global policies and standards.
3. Collaborate across all levels and with external partners.
4. Represent the company during regulatory inspections.
5. Build effective relationships with stakeholders.
6. Participate in departmental and cross-functional meetings.
7. Develop and enforce departmental policies.
8. Perform other duties as assigned.

EDUCATION

• BA or BS in a technical discipline (engineering preferred); advanced degree preferred.

EXPERIENCE

• 16+ years in a GMP environment with knowledge of technology transfer, validation, and quality activities.
• 10+ years in management/supervisory roles overseeing technical activities.
• Strong leadership, technical, management, problem-solving, and project management skills.
• Experience with regulatory inspections and defending departmental functions.
• Technical understanding of facilities, utilities, equipment, and processes.
• Familiarity with regulatory requirements (FDA, MHRA, EMEA, JNDA).
• Excellent technical writing skills.

CONTACTS

This role involves interaction with multiple levels and functions across the organization and external partners.

SUPERVISOR RESPONSIBILITY

This is an individual contributor role with no direct supervisory responsibilities.

Note: This description is not exhaustive and may include other duties as assigned.

Equal Opportunity Employer/Veterans/Disabled

BioMarin is committed to an inclusive environment and equal opportunity employment.

Who We Are

BioMarin is a global biotechnology company dedicated to translating genetic discoveries into medicines that improve human health. Our Technical Operations team builds and maintains manufacturing processes, ensures quality standards, and supports the worldwide distribution of our drugs, focusing on rare genetic diseases.

Join us to make a meaningful impact on patients’ lives.