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Scientist for Biochemistry Laboratory

Protalix is a biopharmaceutical company focused on the development, production, and commercialization of innovative medicines for patients living with rare diseases. With two approved drugs already making an impact, we are committed to expanding our pipeline to address the unmet needs of patients facing some of the most challenging rare diseases.
We are searching for a highly motivated and passionate biochemical scientist to join our interdisciplinary R&D team. In this position you will take part in development and application of a wide range of assays using diverse techniques including enzymatic assays, ELISA, electrophoresis and western blot, capillary electrophoresis, capillary IEF and advanced imaging methods. You will analyze plasma and tissue samples from preclinical studies and will participate in drug and process characterization, assay qualification and QC support. We are looking for an accomplished bench scientist who can work independently while being a strong team player. 

Key Responsibilities:
•    Design and perform experiments
•    Develop bioanalytical methods for protein characterization
•    Contribute to solving problems in diverse disciplines, including process development and analytical assay development 
•    Prepare and review reports and protocols/ technical documentation 
•    Collaborate with internal departments and external vendors and partners 
•    Coordinate existing pipeline projects with members of the R&D team 
•    Assess new technologies

Key Requirements:
•    Ph.D. or M.Sc. with relevant experience in biochemistry, biological science, or biotechnology engineering
•    Experience with relevant bioanalytical methods and lab equipment (hands-on; academic or industry) is a must; 
•    Experience in protein characterization (protein purity, MW, structure, Protein-protein interaction, Enzyme kinetics) is a must
•    Experience in protein purification is an advantage
•    Scientific creativity, curiosity, passion for innovation
•    Independence alongside teamwork and multidisciplinary collaboration capabilities
•    Excellent English writing skills
•    Strong analytical and problem-solving skills
 

Director of Intellectual Property (IP) - part time position

Job Description: Director of Intellectual Property (IP) - part time position

Position Overview: The Director of Intellectual Property (IP) will lead the company’s IP strategy, ensuring the protection and commercialization of intellectual property assets. This role involves overseeing the management of patents, trademarks, trade secrets, and other IP-related matters. The Director will work closely with R&D, product development, legal, regulatory, business teams and external IP counsel to ensure that the company’s IP assets are strategically developed, protected, and leveraged to maximize business value. 

This is a Part-time position based in Karmiel (hybrid model), reporting to VP Clinical Development and Regulatory Affairs.

Key Responsibilities:
•    Develop, implement and manage a comprehensive IP strategy that aligns with the company’s long-term business goals and supports innovation in drug development
•    Work closely with R&D teams, business units, and external partners to identify and protect new inventions and innovations. Collaborate with legal teams and external IP counsel to draft, file, and prosecute patent applications
•    Manage IP licensing agreements and technology transfer activities, including negotiation and drafting of agreements, to maximize the commercial potential of the company's IP assets
•    Conduct IP due diligence in support of business development activities, including licensing and partnerships.
•    Ensure compliance with IP laws and regulations globally, with a particular focus on the pharmaceutical industry’s regulatory landscape
•    Manage IP risks, including monitoring and mitigating potential infringement issues and ensuring freedom-to-operate for new products
•    Foster a culture of innovation and IP awareness within the organization, including training and development programs for R&D and other departments

Qualifications:
•    Advanced degree in biotechnology, biology, or a related field
•    Strong understanding of IP laws, particularly in the context of the pharmaceutical industry
•    Experience of at least 5 years in IP management within the pharma industry, including patent prosecution, portfolio management, and IP strategy development
•    Excellent analytical, organizational, and communication skills
•    Ability to work collaboratively with cross-functional teams, 
•    Knowledge of international IP laws and practices

Preferred Skills:
•    Registered Patent Agent or Attorney (advantage)
•    Experience with IP issues related to biologics, small molecules, drug delivery systems, or other pharmaceutical technologies
•    Familiarity with IP management software and tools
 

Senior Director of Regulatory Affairs and Non-Clinical

Job Description: Senior Director of Regulatory Affairs and Non-Clinical

The Senior Director of Regulatory Affairs and Non-Clinical, is a managerial position responsible for management and overseeing the preparation,  submission and interactions of regulatory submissions (CMC, non clinical and clinical) to health authorities, ensuring that all company products meet legal requirements. This position is also responsible for all toxicology studies required to support the clincial program and regulatory submissions. The role requires strong communication and project management skills to coordinate with internal teams and external stakeholders. He/She will report to the VP of Clinical Development and Regulatory Affairs.

Key responsibilities:
•    Regulatory Strategy Development: Establish and execute regulatory strategies for products, ensuring all necessary applications are filed and compliance is maintained throughout the product lifecycle.
•    Manage and oversee the preparations, review and approval of materials (e.g. briefing package, DSUR, IB, IaND etc) for regulatory submissions, interactions and meetings with Regulatory Authorities (e.g.FDA, EMA, National RA bodies), serve as the company primary contact with regional regulatory advisors.
•    Oversight of the activities related to the authoring and review process (between Protalix, advisors or collaborators) of regulatory documents (such as IB and DSUR), and any update of these documents.
•    Compliance Monitoring: Ensure all company products comply with current regulations, including labeling, packaging, and advertising standards.
•    Cross-Functional Collaboration: Work closely with other departments such as Manufacturing, Clinical, R&D, and Quality Assurance to align regulatory strategies with business objectives and product development.
•    Risk Management: Identify potential regulatory obstacles and develop strategies to mitigate risks associated with product development and marketing.
•    Training & Education: Provide guidance and training to internal teams on regulatory requirements and best practices.
•    Market Intelligence: Stay informed about changes in regulatory policies and guidelines, and assess their impact on the company’s products and processes.
•    Serves as a primary contact for regulatory product-related communications between Protalix and its Partners per product 
•    Establish and execute non-clinical strategies for products under development and ensure that the studies meet the regulatory requirements, and program strategy.

Qualifications:
•    Education: Master's or PhD in a scientific discipline, or an MD or DVM degree
•    Experience: 5+ years of experience in regulatory affairs of innovative drugs within the pharmaceutical industry, with proven experience in managing regulatory submissions.
•    Knowledge: Strong understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines.
•    Management Skills: Proven experience in direct management and leading cross-functional teams.
•    Experience in leading non-clinical studies - advantage
•    Scientific knowledge in therapeutic drugs, recombinant proteins - advantage
•    Experience with regulatory submissions for both drugs and biologics - advantage
•    Communication Skills: Strong written and verbal communication skills, with the ability to present complex regulatory information to a diverse audience

Skills:
•    Excellent written and verbal communication skills in English and Hebrew.
•    Strong direct team management, project management and organizational skills.
•    Ability to work under pressure and meet tight deadlines.
•    Detail-oriented with strong analytical and problem-solving skills.
•    Proficiency in regulatory information management systems.

Tissue culture, Physiology and Molecular Biology of plants Researcher

Job Description: Tissue culture, Physiology and Molecular Biology of plants Researcher

We are seeking an experienced, hands on and dedicated Researcher in Plant Physiology/ Biology/ Molecular biology/ Biotechnology, with expertise in cell cultures and bioreactor cultivation, to join our research team. 
If you are looking for a new challenge and want to be part of a leading research team that leads innovative research with vision and creativity, we invite you to apply for this position.
He/She will report to the Head of Plant cells and Genomic Development.
The position is based in Karmiel.

Job Requirements:
•    Education: Ph.D. / M.Sc in plant Physiology / Biology, or a related field
•    Professional experience: 
    - Minimum 3 years of experience in plant cell culture, including upscaling processes
    - Preferred Qualifications: Experience in recombinant protein expression
•    Knowledge in plant culture media: 
    - In-depth understanding of plant cell culture media and plant hormones
    - Knowledge of plant growth and development processes under controlled conditions
•    Research planning and management skills: 
    - Experience in designing and conducting experiments in plant cell culture
    - Proven ability to analyze and interpret research data
    - Experience in managing research projects, including budgeting and timelines
•    Independence and team work: ability to work independently alongside the ability to collaborate in multidisciplinary teams.
•    Vision and creativity: creative thinking and the ability to promote innovative ideas in the field of plant cell culture research.
•    Diligence and high work ethic: Highly motivated and results-oriented with a strong work ethic. Eager to contribute to the team's success and advancement of company goals.
•    Excellent technical skills: experience working hands on with advanced laboratory equipment and production facility and the ability to implement new technologies. Ability to solve problems creatively and efficiently.
•    Excellent written and oral communication skills – English and Hebrew