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We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

We are looking for a talented Quality Engineer, who will be responsible for the implementation of effective quality controls, inspection methods, and evaluation of the reliability of manufacturing processes, products, and production equipment. Joining the team means being part of an elite group of innovators with a passion for creating future-defining and groundbreaking technologies that shape our everyday lives.

Responsibilities:

* Implement effective quality controls, teach production staff how to use them, and supervise outcomes.
* Implementing inspection methods and evaluating the reliability of manufacturing processes, products, and production equipment.
* Preparing the company for quality audits of customers and international standardization organizations.
* Led CAPA and Root cause analysis, and responsible for task management.
* MRB - Management and tracking.
* Responsible for the company's calibration system.
* Monitors suppliers performance and reports key process indicator to upper management.
* Working in accordance with deadlines for delivery of products.
* Leading certifications of products for new standards & regulations.

We are looking for Process/ Validation engineer

Location: Yahud

Job Description:

Perform validation including writing work instructions and protocols.
Write validation reports (IQ/OQ), support and implement engineering change orders for products, including receiving customer requirements and translating them into engineering requirements.
Provide engineering support for various projects including production processes and integration, as well as addressing issues and non-conformities.

Cell Therapy Quality Control Specialist Flow Cytometry
Advanced Biotherapy Center
Sheba Medical Center, Tel Hashomer
We are looking for a highly motivated individual to perform analytic assays for experimental cell and gene therapies for patients in clinical trials. Your main focus will be on designing and performing flow cytometery assays. You will also perform assays using various techniques including qPCR, ddPCR, ELISA, and bacterial culture.
You will work with various TEST materials including viral vectors, cell banks, primary human cells, and human blood. You will be part of a small team performing required QC assays for both Sheba projects and outside customers. Experience with analytic assays and cell culture in biotech, or pharma laboratory is preferred.
Excellent written English is required. This work may lead to publications in scientific journals and will support clinical trials for treatment of patients with cancer and other types of disease.
Sheba Medical Center is developing and manufacturing new cell and gene therapies for patients with serious diseases. The job holder will report to Dr. Jonathan Esensten at Sheba Medical Center.

For a company specializing in the development and production of machines and saws for cutting silicon and hard materials in the field of microelectronic components
Location: near Yokneam
looking for you
General Job Description : Working to develop & support new and existing products Department: Engineering & R&D Blades Reporting: Engineering & R&D Manager
Responsibilities:
• Optimize the materials, chemical process & procedure • Perform process experiments and optimization • Adapt of new technologies, designs of experiments and new laboratory techniques • Write experimental results and technical reports and present at group and R&D meeting • Record all process information regularly and clearly to allow review and generation of commercial process instructions • Perform application tests with application lab in order to qualify new blade performance • Creating and developing new products to meet market demand • Support and train new staff in all procedures, move R&D to production