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HPLC Analyst - QC Laboratory

Job Description:  HPLC Analyst

At Protalix, our focus is to develop, produce and commercialize potentially better therapies for a variety of illnesses through cutting-edge research and development and our proprietary plant cell-based protein expression platform.
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.

We’re looking for an Analyst for our Protein Chemistry and Glycobiology Laboratory.
 

Responsibilities:

•    Performing analyses on protein and large molecule products using different chromatographic analytical techniques, such as HPLC , Maldi and cIEF.
•    Batch release analysis and stability studies
•    Participation in analytical method validation and qualification studies

Requirements:

•    Preferred: Experience in operation with HPLC (Thermo, Waters).
•    Preferred: Experience in chromatographic software: Chromeleon and Empower
•    Preferred: An understanding of GMP (Good Manufacture Practice) regulatory guidelines
•    Preferred: knowledge in method optimization and validation 
•    Preferred: Computing skills, including use of spreadsheets (e.g. Word, Excel) and work with controlled laboratory documentation.
•    Ability to work collaboratively as well as independently, with proven ability to form strong partnerships with key stakeholders
•    Excellent communication skills – English and Hebrew

Education:

•    B.Sc/B.A. Biotechnology/Biology/Life Science preferably with more than 1 year experience in the industry
•    M.Sc Biotechnology/Biology/Life Science – advantage

Non-Clinical and Clinical Regulatory Affairs Lead

At Protalix, our focus is to develop, produce and commercialize potentially better
therapies for a variety of illnesses through cutting-edge research and development and
our proprietary plant cell-based protein expression platform.
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.
We’re looking for a Non-Clinical and Clinical RA Lead.
The Non-Clinical and Clinical RA Lead is responsible for supporting R&D in its non-clinical planning efforts, planning and managing the Toxicology studies as well as supporting clinical regulatory submissions The individual will work collaboratively with cross-functional teams, including R&D, bioanalytical, clinical and quality as well as liaise with CROs and relevant regulatory consultants. He/She will report to the Head of Regulatory Affairs.

Key Responsibilities:
1.    Non-Clinical Regulatory leader
o    Ensure regulatory compliance of non-clinical studies planned and performed by R&D
o    Plan and execute toxicological studies to support regulatory submissions and product development
o    Review and ensure compliance with Good Laboratory Practices (GLP) and relevant guidelines for non-clinical research
o    Collaborate with external vendors, CROs, and academic partners to ensure the timely and quality completion of non-clinical studies, including liaising with Legal and Finance
2.    Clinical regulatory Leader 
o    Ensure regulatory submission compliance of clinical studies planned and performed by Clinical Team
o    Coordinate with cross-functional teams to compile and submit high-quality, regulatory-complied, clinical section documents within required timelines.
3.    Regulatory Affairs 
o    Maintain up-to-date knowledge of FDA/EU/ICH guidance, submission processes and regulatory pathways
o    Ensure compliance with applicable regulations (FDA, EMA, ICH, etc.) and industry standards
o    Support any regulatory-related submissions activity, as needed
o    Lead the preparation, writing, and submission of non-clinical regulatory documentation required for pre-INDs, Scientific Advice, INDs, CTAs, NDAs, BLAs, MAAs, and amendments
o    Serve as the regulatory subject matter expert in cross-functional project teams

Qualifications:
•    Education: Master's or PhD in a scientific discipline, or an MD or DVM degree
•    Experience: 5+ years of experience in regulatory affairs/ non clinical safety of innovative drugs within the pharmaceutical industry
•    Knowledge: Understanding of global pharmaceutical regulations, including FDA, EMA, and ICH guidelines.
•    Previous experience with vendors’ management and outsourcing 
•    Previous experience working with cross-functional teams and regulatory consultants
•    Experience with regulatory submissions for both drugs and biologics – advantage 

Skills and Competencies:
•    Excellent written and verbal communication skills in English and Hebrew.
•    Strong project management and organizational skills.
•    Ability to manage multiple projects simultaneously and meet tight deadlines

מיקרוביולוג/ית

חברת פרוטליקס היא חברה ביופרמצבטית ישראלית בעלת פלטפורמה טכנולוגית ייחודית לייצור של תרופות ביולוגיות בתאי צמח. החברה ממוקמת בפארק המדע בכרמיאל ומונה כ-200 עובדים (http://protalix.com). 

תיאור התפקיד:

•    עבודת מעבדה בשיטות מיקרוביאליות קלאסיות ( זריעה ישירה, סינון וכד'), בדיקת אנדוטוקסינים בשיטות של ביולוגיה מולקולרית  (PCR  וכד')

•    ליווי תהליך הייצור לכל אורכו, החל משלב המדיה לגידול ועד המוצר הסופי

•    ניטור מערכות  קריטיות של המפעל ומעקב אחר מגמות

•    מעורבות בוולידציות ופיתוח שיטות מיקרוביאליות, ניסויים ותחקירים

דרישות התפקיד: 

•    תואר ראשון רלוונטי/ הנדסאי עם ניסיון רלוונטי

•    לפחות חצי שנה ניסיון בעבודת מעבדה / במסגרת פרויקט התמחות - חובה

•    ניסיון בשיטות עבודה מיקרוביולוגיות קלאסיות: זריעת חיידקים, ספירה וכדומה – יתרון

•    ניסיון בשיטות עבודה בביולוגיה מולקולארית – יתרון

•    יכולת עבודה בצוות

•    יכולת עבודה תוך ריבוי משימות ונכונות לעבודה מחוץ לשעות העבודה במידת הצורך

•    יכולת עבודה בשיטתיות, סדר וארגון 

•    שליטה טובה בעברית ובאנגלית 

•    העבודה בכרמיאל