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 debilit

Create and/or revise product specification documents, following MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled document management system (Veeva). Initiate and set up change control workflows for product specification revisions in Veeva and BioMarin's quality management system. Coordinate Veeva change control workflows for review and approval of product

Provide strategic guidance on design and execution of oligo based drug discovery programs. Lead the Oligonucleotide Chemistry Team ensuring the timely delivery of high quality, well characterized material to support oligo program s across the research portfolio . Integrate chemistry and delivery strategies in collaboration with the Bioconjugation and Analytical leads to d

DESCRIPTION This position is embedded in the US Medical Affairs organization and is responsible for medical leadership for BioMarin's growth related conditions medicines and programs. This responsibility includes leadership and direction across US medical team to ensure strategic alignment and integration at the global level of regionally driven priorities. This individual

s required. Skillful application of KPI's and metrics to manage business processes and support strong team performance. Proficient and comfortable working indirectly through others. Lives the TOP Cultural values lead with compassion, pursue quality & integrity, better together. ADDITIONAL DETAILS Some additional benefits provided at BioMarin are Work flexibility (hybrid on

The greater Supply Chain Operations department is responsible for the site production planning and scheduling, ready process, warehouse operations, operational purchasing, ERP recipe management, as well as oversight of receipt and shipping of all materials to and from our External sites. Specifically, under the remit of the Planning Operations Lead will be Ready Process I

Develop category strategy Develop in depth knowledge of category specifications, BioMarin products, and processes and regulatory requirements. Works in collaboration with key business functions, to drive execution of category strategy projects and programs, including drafting and socializing project charters. Utilize spend analytic and market intelligence tools to identif

Who We Are 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 ensur

DESCRIPTION The Manager, External Quality Planner reports to the Director of QA CMO Operations and is responsible for oversight of processes to ensure on time batch release for External Quality as per long range planning requirements. In addition, this role is responsible for alignment of Quality Capacity within the Supply Planning Cycle, including maintenance of associate

In this newly created role, the Head of Corporate Real Estate (CRE) will be responsible for BioMarin's real estate strategy for our global portfolio, including strategic planning, site selection, negotiations, lease renewals, transaction management, and workplace strategy and implementation. This individual will report directly into BioMarin's Executive Vice President, Ch

DESCRIPTION The Senior Technical Manager, Supplier Quality Management (SQM) will be responsible for owning and ensuring the quality and compliance of a category of supplier's within BioMarin's global supplier network. Emphasis will be on Single Use Technologies (SUTs) such as Filters, Bioprocess Containers, Reusable Tubing Assemblies, and some Consumables used in BioMarin'

BioMarin has experienced substantial growth organically since its inception, primarily over the last decade. While this steady growth in both cost structure and staff was essential to BioMarin's emergence as a leading, fully integrated global biopharma with approximately $2 billion in revenues from over 75 countries, a robust R&D pipeline, operating profits, and world cla

The Head of Global Cyber Security is responsible for BioMarin's overall cybersecurity strategy, personnel, processes, and technologies. Reporting to the Senior Vice President and Chief Information Officer, Information Technology, this senior level role will be a key member in the IT Leadership Team, providing cybersecurity oversight and guidance for BioMarin. The Head of

Provide technical oversight for product (s) manufacturing/testing executed at external and internal partners. Act as Technical Development technical representative on process teams. Act as an SME on biologic Drug Product, including technology transfer, process validation, trouble shooting and investigation on specific product(s). Participate in cross functional teams, as

Shift Details Swing shift, 4 10hr shifts (Wednesday Saturday) 11am 10pm onsite in Novato, CA The Quality Control Microbiology (QCM) Supervisor is responsible for supervising a GMP laboratories supporting microbial test and release of drug substance intermediates from biopharmaceutical manufacturing from cell culture up through final formulation and the environmental monit