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The Technical Writer is responsible for designing and updating controlled procedures owned by Novato Engineering and Facilities Services (NEFS). The Technical Writer frequently works with cross functional teams in TOPS including Engineering, Quality Assurance, Maintenance, Instrumentation, Maintenance Business Office, Automation, Manufacturing, and Capital Project Management. This position require
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This position reports to the Head of Global Supplier Quality and will support and maintain Quality oversight for one of the Global Supplier Quality processes associated with the following Raw Material Supplier Changes, Supplier Investigations, the Approved Supplier List (ALS) and associated Purchasing Controls and Quality Agreements for Raw Material Suppliers, and Raw Material Specification Oversi
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DESCRIPTION The Technical Manager, Global Quality Systems is primarily responsible for the oversight and maintenance of the Annual Product Review process across all product lines. The role is also responsible for driving proactive compliance to quality system requirements through self inspection, business process ownership and other quality oversight activities as required. This position requires
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Maintain enterprise scale applications used in laboratory and manufacturing areas Implement and maintain stand alone laboratory analyzer workstations and applications Design and maintain special purpose computers supporting scientific compute (e.g., multi GPU) Ability to design, document and communicate complex laboratory workflows and requirements Author System Development Lifecycle (SDLC) suppor
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Leadership Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight Accomplishes tasks through direct and effective coordination Provides direction and hands on training for staff Management of staff Lives department values and sets the standards for others to operate Fosters an e
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Perform independent review and approval of standard operating procedures and policies related to method life cycle management including validation, verification, transfer, evaluation and setting specification limits for release and stability testing, critical reagent and reference standard management. Review technical content of method submissions to regulatory authorities. Formalize business proc
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BioMarin is a 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,
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Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development Work closely with collaborators on animal models of disease including an in depth understanding of disease etiology Design, implement, report and interpret nonclinical study data of small molecule, biologic or other novel drug candidate
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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
Posted Today
The selected candidate will work in the Chemical, Formulation and Device Development (CFDD) group to advance therapeutic proteins, peptides, and gene therapy vectors for clinical and commercial applicatio ns. The candidate will be responsible for parenteral and solid dosage formulation development , product characterization and supporting m anufacturing processes for drug products. The selected c
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Develop and execute Hemophilia scientific plans within their region to meet company defined goals within corporate and regulatory guidelines for products both marketed and in development Visit potential research sites to determine the site's ability to conduct and accrue within clinical research studies and registries (i.e. patient volume, research experience, methodologies, competing studies) Imp
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Develop and execute Hemophilia scientific plans within their region to meet company defined goals within corporate and regulatory guidelines for products both marketed and in development Visit potential research sites to determine the site's ability to conduct and accrue within clinical research studies and registries (i.e. patient volume, research experience, methodologies, competing studies) Imp
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The Global Financial Planning and Analysis (FP&A) team is responsible for the coordination, consolidation and reporting and analysis of the company's budget, forecasts and long range plan.The position,will support the FP&A team in all aspects of the budgeting and forecasting processes, planning for corporate items, financial analysis and support and management reporting. This position will also pl
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The RNC Sr. Manager/ Associate Director responsibilities may vary depending upon product regulatory lifecycle and may include the leadership of selected activities which will be delegated by the Regulatory Nonclinical/ Clinical Lead and may include the following Development Stage Product Support the development of the nonclinical / clinical regulatory strategy and plan. Assist with selected planni
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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
Posted Today
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