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לוח משרות דרושים, נמצאו 4 משרות עבודה בתחום ביוכימיה

המשרות באתר מיועדות לנשים וגברים כאחד
תיאור תפקיד:
לחברת תרופות בינלאומית !!! מתאים גם לסטודנטים 
יש מערך הסעות 
ביצוע בדיקות לשחרור מוצרים וחומרי גלם, בדיקות יציבות עבודה תהליכית ושימוש במגוון טכניקות אנליטיות ועבודה על מכשור כמו: GC/HPLC
דרישות:
השכלה אקדמית בכימיה/ ביולוגיה -חובה.
ניסיון של שנה לפחות ככימאי/ת במעבדה- יתרון משמעותי
נכונות לעבודת משמרות (בוקר/צהריים)
היקף משרה: משרה מלאה, משמרות, לפי שעות
קוד משרה: 8555
קרא עוד
תיאור תפקיד:
• Lead development projects for fed-batch and perfusion- processes in bioreactor systems at various scales achieving high yielding protein production (clone selection, media and feed development, seed train optimization and scale-up)
• Ongoing day to day support of bioreactors process
• Implementation of high throughput technologies
• Stay current in new technology and regulations with respect to both process development and manufacturing
• Writing and review of technical documents including protocols, reports, SOPs & risk assessments, etc.
• Lead upstream related CMC studies with understanding of statistical design of experiments and advanced data analysis
• Coordinate information and documents for regulatory filings
• Conduct technical discussions & meetings with internal stakeholders including Product & Process Research, Downstream Development, QA and RA to facilitate implementation of new technologies
• Present results at internal and external meetings
• Excellent organizational, interpersonal, communication and problem-solving skills
דרישות:
• Ph.D. or equivalent in Biomedical Engineering, Biotechnology Engineering, Biotechnology, Biology or Biochemistry
• Minimum of 3 years relevant experience, biotechnology or pharma setting
• Previous hands-on experience with mammalian cell culture
• Experience with process development and characterization and related process data analysis Excellent organizational and technical skills
• Ability to manage concurrent deliverables and work effectively with others in a challenging, milestone-driven environment
• Ability to diversify technical skills in a fast-paced organization
• Strong written and verbal communication skills in English
היקף משרה: משרה מלאה
קוד משרה: JB-00072
קרא עוד
תיאור תפקיד:
• Plane lead and execute pharmaceutical analytical experiments
• Responsible for development of characterization studies
• Responsible for validations of analytical methods and tech- transfer methods
• Management of CRO’s
• Author and review documents, reports, procedures.
• Scientific support to regulatory requirements and questions from regulatory authorities and e-CTD submissions
• Present information and data in both written
דרישות:
• PhD, or MS in biotechnology, chemical engineering, life sciences or equivalent
• 3+ years of biopharmaceutical industry experience
• Knowledge in characterization studied of pharmaceuticals
• Knowledge in regulatory requirements and experience in regulatory responses
• Strong ability in execution and driving for results independently
• Detail oriented with good organizational skills and able to work in a high paced team environment to meet deadlines and prioritize work on multiple projects.
• Excellent communication skills, both verbal and written, and the ability to build and maintain relationships with team members, partners, customers, and collaborators.
• Fluent English in speaking and writing

היקף משרה: משרה מלאה
קוד משרה: JB-00067
קרא עוד
תיאור תפקיד:
· Responsible for regulatory submissions, approvals and compliance for worldwide market expansions and renewals
· Full understanding of regulatory file template and ability to maintain and update the quality part (CMC sections) in regulatory file
· Evaluate change requests and regulatory impact and establish the appropriate strategy for the projects at BTG
· Ability to write variations/ supplements and to drive approvals globally
· Maintain collaborative work with regulatory teams within BTG and globally
· Provide regulatory support to development activities and drive clinical trial application under development projects
· Review and approve Protocols, Reports and Validation documents
· Responsible for continuously acquiring new knowledge and finding innovative solutions to regulatory challenges and issues
· Provide regulatory CMC intelligence to cross-functional teams
· Demonstration of full understanding of regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) and demonstrate regulatory CMC expertise.

דרישות:

· Academic degree in science (MSc or PhD) in any area of biology, life sciences or molecular biology - must
· Hebrew and English at mother tongue level, with proven abilities in writing and editing of submission documents – must.
· At least 5 years experience in the pharma industry, or 3 years in regulatory affairs and product registration of pharma products – must
· Excellent oral and written communication skills, with ability to work as part of a team- must
· Scientific understanding of CMC requirements and submission content concerning product quality- an advantage
· Ability to simultaneously manage and drive multiple projects to achieve new registration and support change variations - must
· Ability to work independently, work under pressure and to meet changing deadlines- must
· Logical thinking, assertiveness, creativity and flexibility - must
· Computer literacy, including experience with Microsoft Office Word, Excel and Power Point.
· Understanding of GMP and Quality System requirements – an advantage
· Computer literacy, including experience with Microsoft Office Word, Excel and Power Point.
· Knowledge of and experience with US and EU regulatory requirements for the biopharma industry (drugs, medical devices, biologicals) - an advantage.
היקף משרה: משרה מלאה
קוד משרה: 3275
קרא עוד

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