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Validation Engineer for Computerized Systems

Protalix is a biopharmaceutical company focused on the development, production, and commercialization of recombinant therapeutic proteins produced by our proprietary ProCellEx® plant cell-based protein expression system. The company is located in the Science Park in Karmiel and has 200 employees.

We are looking for a Validation Engineer for Computerized Systems.

Job Description:
•    Managing and leading validation projects for computerized systems from development to implementation
•    Planning and performing software tests
•    Setting up and qualifying computerized systems / IT Systems
•    Writing documents such as user requirements, protocols, and risk assessments
•    Performing supplier audits for computerized systems

Job Requirements:
•    B.SC in Industrial Management Engineering specializing in information systems or Information Systems/Computer Science Engineer. Alternatively – a Bachelor's Degree with one or more years of experience in the field of computer validation 
•    Essential: Knowledge in software development and testing methodologies
•    Essential: Knowledge in computer systems, databases, control and automation, and networks
•    Preferred: Pharmaceuticals experience
•    Problem-solving savvy
•    Self-motivated & Strong interpersonal and communication skills
•    Ability to work collaboratively as well as independently
•    Excellent communication skills – English and Hebrew

Corporate Counsel

Protalix BioTherapeutics is a pharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs. To date, we have specialized in producing recombinant protein drugs in our proprietary plant cell-based protein expression system, ProCellEx®, and improving their characteristics using chemical modifications. We have brought to market two pharmaceutical products that are based on recombinant proteins. Currently, we are turning our focus to new, early-stage product candidates with an emphasis on treatments of renal diseases. This focus will involve our ProCellEx platform, as well as other modalities such as small molecules and antibodies. We are also exploring novel platform technologies. If you wish to be a part of our success and join a dynamic and professional team that allows personal and professional growth, we are looking for you.

Responsibilities
We are looking for a corporate counsel to join our legal team; the legal team is part of our Finance Department. Responsibilities include:

•    Commercial contract drafting and review; maintenance of contract life cycles
•    Commercial alliance management (in-licensing and out-licensing)
•    Corporate governance matters
•    Drafting and review of disclosure documents
•    Securities law compliance
•    Stock exchange compliance
•    Data privacy management
•    Employment matters
•    Facilitation of investor and stockholder relations matters

Key Requirements
•    Member in good standing of the Israeli Bar
•    Four years or more experience in large law firm (Israeli or U.S.) in commercial or corporate department
•    Legal experience in NYSE American regulations and Date Privacy a plus 
•    Self-motivated with strong organizational skills
•    Ability to work collaboratively as well as independently, with proven ability to form strong partnerships with key internal stakeholders
•    Working knowledge of Microsoft Word, Excel, Outlook and similar software programs
•    Excellent communication skills – English and Hebrew
•    Strong writing skills – English and Hebrew

Education

LL.B. (or foreign equivalent)

 

 

Pharmacovigilance Associate

Protalix BioTherapeutics is a pharmaceutical company developing innovative therapies for rare diseases with significant unmet needs. We leverage our proprietary plant cell–based protein expression platform, ProCellEx®, along with other modalities including small molecules and antibodies.
Protalix has successfully commercialized two recombinant protein–based products, is advancing a gout program currently in Phase 2 development, and continues to build a pipeline focused on renal diseases while exploring novel technologies and early-stage opportunities.
If you are looking to join a dynamic, professional team that supports personal and career growth, we would be happy to hear from you.
Key Responsibilities
•    Manage the company’s safety surveillance activities for products under clinical development,     including case processing, periodic safety data assessments, signal detection, literature reviews,   preparation and coordination of internal safety committees, and maintenance of an overall safety   surveillance plan.
•    Develop, maintain, and deliver training on internal PV SOPs and safety procedures, ensuring     alignment with evolving regulatory requirements.
•    Review/contribute to safety content for clinical and regulatory documents, including IBs,   protocols, ICFs, CSRs, and DSURs.
•    Execute and manage Safety Data Exchange Agreements (SDEA) with partners for post-   marketing products.
•    Support and manage clinical trial operations activities throughout the clinical study lifecycle. 
Required Expertise and Experience
•    Proven experience in Pharmacovigilance and Safety management within a pharmaceutical or   biotechnology environment (≥5 years).
•    Strong knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GCP, FDA,   EMA).
•    Hands-on experience in managing safety activities in clinical trials.  
•    Working with external safety/pharmacovigilance vendors, CROs, and partners - advantage.
•    Experience in clinical operation activities including study start-up, conduct, and close-out.   Review  and support study plans, experience in eCRF, IRT, and eTMF activities and ensure   appropriate clinical trial monitoring and documentation – advantage.
•    Ability to work independently, manage multiple priorities, and lead safety and operational   activities end-to-end.
•    Strong communication, organizational and cross functional collaboration skills.
•    High level verbal and written English.
•    The position is in Karmiel
•    Presence on site at least 3 times a week 
Education
•    BSc or MSc in Life Sciences, Pharmacy, Medicine, Nursing, Public Health, or a related scientific   discipline.
•    Advanced degree (PharmD, MD, or PhD) – an advantage.

 

Scientist for Biochemistry Laboratory

Protalix BioTherapeutics is a pharmaceutical company specializing in producing recombinant protein drugs in plant cell and improving their characteristics using chemical modifications. Protalix is searching for a highly motivated and passionate biochemical scientist to join our interdisciplinary R&D team. We are excited about offering our employees the challenges, responsibilities, and learning experiences needed for their personal and professional development and growth. You will receive the opportunity to take part in the design of new and improved drugs including biochemical assay development; kinetic activity, ELISA, western blot, capillary electrophoresis, capillary IEF, etc. In addition, protein and process characterization, assay qualification and QC support. We are looking for a person that can work independently, but can also work together with a team of excellent minds. We welcome open minds and out-of-the-box thinking that come from international multidisciplinary teamwork.

Key Responsibilities:
•    Perform experiments in bioanalytical methods for protein characterization
•    Contribute to solving problems in diverse disciplines, including process development and analytical assay development  
•    Coordinate existing assays with members of the R&D team 

Key Requirements:
•    M.Sc. or BSc with relevant experience in biochemistry, biological science, or biotechnology engineering
•    Experience in bioanalytical methods, protein characterization (hands-on; academic or industry) 

 

 

 

עובד/ת ייצור

חברת פרוטליקס היא חברה ביופרמצבטית ישראלית בעלת פלטפורמה טכנולוגית ייחודית לייצור של תרופות ביולוגיות בתאי צמח.  מערך הייצור אחראי על יצור התרופות של פרוטליקס. העבודה ביצור היא קשה ומתבצעת
"סביב השעון"- עבודה במשמרות (בוקר, צהריים, ערב/לילה), כולל עבודה בימי שישי ומוצאי שבת.

העבודה כוללת משימות כמו: הכנת מצעי מזון ובופרים בנפחים של מאות ליטרים, הרצה של קולונות כולל הכנות נדרשות, התקנה ותחזוקה שוטפת של ביוראקטורים (העלאת נפחים, פיצול, קציר והזנת מדיה), שטיפות וניקיונות של המערכות השונות. העבודה נעשית בחדרים נקיים, תוך הקפדה על כללי לבוש ותיעוד ברורים ומחמירים בהתאם לדרישות ה- GMP. העובדים במערך היצור, צריכים להיות מקצועיים, מיומנים ומחויבים למשימות. אצלנו נהנים מעבודת צוות טובה ותומכת, עבודה עם ציוד חדיש, עבודה עם אחריות. הנכם מוזמנים להיות חלק מפרוטליקס ולקחת חלק בעשייה ביוטכנולוגית מתקדמת ומובילה.

דרישות התפקיד:

• הנדסאי ביוטכנולוגיה / כימיה/ ביולוגיה
• ניסיון בעבודה במפעל פארמצבטי בסביבת GMP  - יתרון
• נכונות לעבודה במשמרות (בוקר, ערב, לילה) ,שעות נוספות וימי שישי
• חוש טכני טוב
• יכולת למידה
• בעל/ת רכב – נדרשת יכולת הגעה עצמאית
• העבודה בכרמיאל