Principle Engineer –Global Technology Transfer, Business Process
Technology transfer is a pivotal componentof a drug product’s life cycle managementas 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 isfocused 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 inand 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.).
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.
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.
KEY RESPONSIBILITIES - Leadership
Standardize and publish global policies, best practices and standards across sites to streamline technology transfer activities, governance, and decision making.
10+ years’ experience in a management or supervisory position, with direct experience overseeing technology transfer, validation, and technical activities.
Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending technology transfer preferred, but not required).
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.
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.
The salary range for this position is: $148,000 to $203,500. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit:
https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.