תל חי

Lead and manage the analytical department Analytical methods development Planning, performing, and managing analytical validations/qualification Scientific writing, protocols, reports, SOP’s under GMP requirements Design and write products specifications Reviewing of analytical results executed by the lab/CDMOs Task execution according to projects timelines Intensive cooperation with QA and other R&D departments

- ביצוע ויישום פרויקטים משתנים בנושא קידום בינלאומיות מול גורמים במכללה/גורמי חוץ. - טיפול בתכנון ותפעול ביקורים בינלאומיים. - אחריות על הפקת סדנאות וקורסים בינ"ל (מנהלתית). - הכנת חומרי רקע, מצגות, עדכון חומרים באתר, הכנת חומרים לפרסום ושיווק. - טיפול מנהלי בסטודנטים בינ"ל.

למעבדה במיגל בראשות פרופ' גיורא ריטבו דרוש/ה עוזר/ת מחקר לפרויקט העוסק בטכנולוגיית פירוק פוטוקטליטי של מזהמים במערכות מים ושפכים.

MigVax Ltd. a mid-stage startup company that develope vaccine to covid-19, is looking for a Research assistant – Assay development to join the Process Development Department.

Job Description:

Development of analytical, biological, and biochemical methods. Analytical support for the process development department. Scientific writing, protocols, reports, and procedures.

MigVax Ltd. a mid-stage startup company that develope vaccine to covid-19, is looking for an experianced QA/RA manager to join our team.

Responsibilities: Manage Quality Assurance and Regulatory Affairs on behalf of the company Develop regulatory strategy, prepare technical and submissions filings based on each country’s regulatory requirements. Manage the quality of the product and QMS, provide QA and regulatory guidance to company departments (Manufacturing, R&D, etc.), document control, manage the CAPA and MRB processes. Perform and oversee risk analysis, conduct internal-external and supplier audits, manage and participate in all quality processes in the company. writing and maintaining design controls and risk management processes Manage documentation control and training activities.

חברה המפתחת חיסון פומי כנגד COVID-19, מגייסת צוות מחקר מנוסה בניקוי והפקת חלבונים.

MigVax is developing an oral subunit vaccine for COVID-19. MigVax team has combined decades of track record with successful global vaccine and pharmaceutical achievements. Requirement: • Proficiency in Quality Assurance aspects of biological drug development o Knowledge of GMP-based requirements o Training of R&D teams in QA aspects, follow up on daily documentation and work performance o Design and establishment of a Controlled Documents Bank o Support writing of SOPs, working instructions, protocols etc for all experimental work; design of forms for experiment documentation o Design of qualification and validation of assays in collaboration with R&D team, support performance and report writing o Definition of QA requirements for equipment, follow up on calibration and maintenance o Good insights into Quality Control requirements for Biologics • Good understanding in Protein Biochemistry o Protein expression in different expression systems o Protein purification – SEC, Inversed Phase, affinity (Akta) o Protein analysis: ELISA, WB, impurities (HPLC) o Chemical analysis o Protein activity analysis: In vitro and cell-based assays

MigVax is developing an oral subunit vaccine for COVID-19. Humanity has never faced such a challenge - develop a vaccine within 18 months! MigVax team has combined decades of track record with successful global vaccine and pharmaceutical achievements. • Requirements Proficiency in Protein Biochemistry(hands on): o Protein expression in E coli, yeast, insect and/or mammalian cells o Protein purification – SEC, Inversed Phase, affinity (Akta) o Manufacturing process development o Protein analysis: ELISA, WB, impurities (HPLC) o Protein activity analysis: Cell-based assays development and performance, binding assays o Experience in assay qualification and validation is a great advantage o Knowledge of GMP-based documentation in an R&D environment • Experience in writing of quality documents: SOPs, protocols, research reports • Experience in the writing of the scientific part of CMC (under RA support) – big advantage • Team management experience is an advantage. • Subcontractors daily management and guidance/collaboration experience is an advantage.

MigVax is developing an oral subunit vaccine for COVID-19. Humanity has never faced such a challenge - develop a vaccine within 18 months! MigVax team has combined decades of track record with successful global vaccine and pharmaceutical achievements. • Requirements Proficiency in Protein Biochemistry(hands on): o Protein expression in E coli, yeast, insect and/or mammalian cells o Protein purification – SEC, Inversed Phase, affinity (Akta) o Manufacturing process development o Protein analysis: ELISA, WB, impurities (HPLC) o Protein activity analysis: Cell-based assays development and performance, binding assays o Experience in assay qualification and validation is a great advantage o Knowledge of GMP-based documentation in an R&D environment • Experience in writing of quality documents: SOPs, protocols, research reports • Experience in the writing of the scientific part of CMC (under RA support) – big advantage • Team management experience is an advantage. • Subcontractors daily management and guidance/collaboration experience is an advantage.

MigVax is developing an oral subunit vaccine for COVID-19. MigVax team has combined decades of track record with successful global vaccine and pharmaceutical achievements. Requirement: • Proficiency in Quality Assurance aspects of biological drug development o Knowledge of GMP-based requirements o Training of R&D teams in QA aspects, follow up on daily documentation and work performance o Design and establishment of a Controlled Documents Bank o Support writing of SOPs, working instructions, protocols etc for all experimental work; design of forms for experiment documentation o Design of qualification and validation of assays in collaboration with R&D team, support performance and report writing o Definition of QA requirements for equipment, follow up on calibration and maintenance o Good insights into Quality Control requirements for Biologics • Good understanding in Protein Biochemistry o Protein expression in different expression systems o Protein purification – SEC, Inversed Phase, affinity (Akta) o Protein analysis: ELISA, WB, impurities (HPLC) o Chemical analysis o Protein activity analysis: In vitro and cell-based assays