Principal Engineer, Global Technology Transfer, Business Process

BioMarin PharmaceuticalNovato, California

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Job Description

Description

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 Drug Substance, Drug Product, 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 BioMarin TT departmental playbooks, documentation, tools and templates for phase appropriate planning, process and facility knowledge consolidation, operational readiness, and risk management that ensure successful technology transfers over the product’s lifecycle.

Reporting to the Sr. Director of Global 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, reports, 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 technology 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 leadership on decisions related to technology transfer strategy that are critical to the success of the TOPS business objectives.

KEY RESPONSIBILITIES - Leadership

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 external partners on significant matters often requiring coordination and collaboration across sites.

Represent the company as the technology transfer subject matter expert during internal and external regulatory inspections, as needed.

Establish effective communication and collaborative relationships with other functional groups and key stakeholders.

Participate in multi-departmental meetings and project teams, representing functional groups.

Develop, define, and enforce departmental policies and practices for functional groups.

Other duties as assigned

EDUCATION

BA or BS in a technical discipline (engineering preferred but not ); advanced degree preferred.

EXPERIENCE

16+ years’ experience in a GMP regulated environment, with exhibited knowledge and proficiency of technology transfer, validation and quality activities.

10+ years’ experience in a management or supervisory position, with direct experience overseeing technology transfer, validation, and technical activities.

Excellent leadership, technical, management, problem solving and project management skills.

Organizational and management skills to handle multiple functional groups, with ability to effectively delegate work.

Ability to speak, present data, and defend approaches in front of audiences and inspectors.

Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending technology transfer preferred, but not ).

Ability to comprehend technical information related to facilities, utilities, equipment, processes, computer validation, scientific approaches, and regulatory expectations.

Understanding and familiarity with broad regulatory (e.g., FDA, MHRA, EMEA, JNDA, etc.) requirements, guidelines, and recommendations for departmental functions – understanding of regulatory guidelines for other countries a plus.

Exemplary technical writing skills

CONTACTS

This position will require interaction with multiple levels (from entry level employees up to Senior/Executive Management) in GPS, Technical Development, Quality, Corporate Compliance, Manufacturing, Engineering, Facilities, Contract Manufacturing, Regulatory Affairs, IT, Clinical Operations, Medical Affairs, Legal, Accounting, Finance, and Human Resources.

SUPERVISOR RESPONSIBILITY

This position is considered an individual contributor role. Direct supervisory skills are not anticipated.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.