לוח משרות דרושים מדעי החיים, טבע וחקלאות

A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

We are hiring a senior data scientist to join Nucleai’s data science team. A cancer patient wants to know that their diagnosis and treatment are determined with the greatest precision and preferably using the most advanced technology. At Nucleai, we bring cancer patients cutting-edge AI-based technology by improving biopsy interpretation with machine learning and creating novel precision medicine technology. Come join our team of experienced AI engineers and world-renowned clinicians, and help us make a difference. At Nucleai, we believe that talents are our most valued asset, and as such, hiring the right people is one of our most strategic missions.
Position Overview The data science team provides the bottom line to our customers – which patients are the best fit for a cancer treatment and what is the chance of success. We do it by analyzing medical images and clinical data, researching spatial features, developing predictive models and applying statistical methods to evaluate the results. We work together with subject-matter experts, from medical doctors to software engineers, to leverage computer vision, focus on the most promising biological hypotheses and to productionize our capabilities.
Responsibilities:
* Independently lead the data science perspective in any project or assignment – from data mining, through developing new algorithms, to analyzing results and providing professional insights and guidelines.
* Contribute to the team's internal codebase with high-quality code and development standards.
* Augment our knowledge and best practices, adopt relevant SOTA data science methods and practices.
* Work closely with medical doctors, product and project managers, research scientists and software developers to focus your efforts, build new capabilities and provide value to your colleagues and our customers.

Required Analyst
Job Description:
A clinical-stage drug discovery and development company in the field of cancer immunotherapy. In line with our business model to enter into collaborations for their internally discovered, novel therapeutic candidates at various stages in research and development, the company is seeking an Analyst in support of its partnering efforts.
Reporting to the SVP Strategic Collaborations, the Analyst will lead competitive intelligence (CI) and business analysis activities to support BD and corporate objectives. She/he will be responsible for supporting aspects of competitive analysis and other activities relating to partnering efforts.
Constantly monitor the pharma and biotech space and gather competitive intelligence from various sources including company portfolios, preclinical and clinical activities, scientific data, partnerships, deal structures and terms, and other relevant intelligence
Perform analyses and provide insights into competitive landscapes, industry trends and perspectives, market developments, product developments and positioning, as well as other intelligence in support of our BD&L and R&D efforts
Provide regular updates to our management and functions
Develop Target Product Profiles for our development candidates in close collaboration with R&D teams, and build forecast models based on epidemiological data as well as customer/patient segmentation, pricing and access assumptions
Identify potential collaboration partners for various pipeline opportunities
Work closely with our R&D community and drive the preparation of materials surrounding the companys pipeline programs for internal presentation to management and also to potential partners
Contribute to the creation of valuation models and financial valuation of business development opportunities against partnering scenarios.

Required Research Lab Technician
Job Description:
The research technician will support ex-vivo and in-vitro experiments, as a part of the functional validation of immunomodulatory molecules discovered by us.
The research work under the supervision of scientists will include expression studies in human and mouse tumor-infiltrating immune cells, and functional immune assays for elucidation of mode of action.
Assist in processing and characterizing human and mouse tumor tissues
Perform immune cell isolation from human and mouse blood
Support tissue culture experiments (flow cytometry, cytokine analysis)
Assist in genotyping of mouse strains
Support with laboratory maintenance duties e.g., handling routine tasks such as preparing stocks of common lab reagents, maintaining lab databases, etc.
Temporary position until the end of the year 10 hours a week.

Required Translational and Bioanalytical Research Associate
Job Description
The Translational and bioanalytical research associate will oversee the Companys translational and bioanalytical activities that are essential for drug development activities, preclinical and clinical. This typically includes bioanalytical methods development and use for pharmacokinetic and immunogenicity evaluation, as well as methods needed for pharmacodynamic exploration, such as cytokines, receptor occupancy, immunophenotyping, and a support for drug manufacturing development activities (CMC). The candidate will ensure the methods are developed, validated, and used with the highest degree of quality and compliance with international regulations.
The candidate will work with cross functional teams across the organization (preclinical biomarker/translational research, clinical development, clinical operations, CMC, regulatory, clinical data management) to ensure the successful PK and PD sample analysis for investigational drugs in our pipeline.
Be responsible for the bioanalytical methods required for our various therapeutic programs at preclinical and clinical development stage. This includes assay set-up, optimization, validation, execution, tracking of program and study timelines, review of bioanalytical protocols and reports
Propose format and strategy for pharmacokinetic and pharmacodynamic assays, immunogenicity assays such as ADA and NAb assay, flow cytometry immunophenotyping panels, Receptor occupancy assays, etc.)
Support the selection and the oversight of external advisors/Contract Research Organizations, including participating to quality assurance audits
Monitor internal and external work on bioanalytical methods
Collaborate with scientific colleagues in the R&D units from discovery to clinical teams
Maintain an up-to-date understanding of the state-of-the-Art literature, requirements, and regulatory guidelines for bioanalytical methods used in drug development
Present written and oral reports to preclinical units and management
Contribute to Project Management activities such as definition of activities, timelines, and costs/budgets
Contribute to the data analysis and summaries of results derived from pre-clinical and clinical sample analysis
Contribute to preclinical and clinical documentation definition and writing for the sections related to bioanalytical methods.