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Available openings in U.S.,
Israel, or Europe:
Executive Assistant, Omrix Ltd.
Responsibilities:
- Point of contact for the CEO and senior management team.
- Prepare and route mission-critical term sheets, contracts,
correspondence and other documents.
- Manage executive schedules, coordinate internal and external
meetings and plan corporate-wide events.
- Arrange executive travel itineraries, process expense reports,
screen telephone calls and greet customers/partners.
- Facilitate all aspects of VIP candidate and client visits
including travel, scheduling, lunches, dinners, etc.
- Attend meetings, capture and distribute meeting minutes.
- Overall responsibility for all administrative duties as requested,
such as maintaining and organizing filing systems, maintaining
a press kit, scan, copy, mail, fax, shipping, etc., as well
as personal errands.
- Administrative support to the CEO, ILGM, Plant Manager
Qualifications:
- Fluent in English - very good oral and written communications
skills are essential. (Must effectively communicate with all
levels of management, the team and third-parties).
- Ability to multi task, work independently, set priorities,
and complete work timely and accurately.
- Ability to apply critical thinking to tasks, creatively approach
challenges and solve problems.
- 2-3 years of prior administrative experience supporting senior
level executives and clients.
- Academic degree
- Proficient in Microsoft Office suite.
This position reports to the CEO and Israel General Manager.
Availability: Full-time. 09:00 - 18:00
QA assistant for R&D Department, Omrix Ltd.
Responsibilities:
- The main objective for this role is to assist with the management
of the Quality System, audit requests, production certification.
- Prepare quality records and SOP’s relevant to both subcontractors
and internal production.
- Assist with generation of Non-Conformance reports and customer
complaints.
Qualifications:
- MS.c in Life science/chemistry
- A minimum of 2 years experience in a pharmaceutical / biotechnology
company within a GMP environment
- Previous laboratory experience in biochemistry or biology
-an advantage.
- Experience with writing SOP’s
- Proficient in Microsoft Office suite
- Pedantic
- Good organizational skills
- written communications skills are essential
- English - high level
- Reporting to the Lab manager
Engineering Manager, Omrix Ltd.
Responsibilities:
- Responsibility over all engineering and maintenance aspects
in the plant.
- Carrying out projects in the manufacturing systems, utilities
and construction.
- Engineering designing
Qualifications:
- B.Sc. in Mechanical Engineering/ Electro-Mechanics
- Technical English
- 5 years experience as a engineering manager in the Pharmaceutical/food
industry.
- Former knowledge in systems: water distillers, turbine systems,
biology production systems (UF, Colonas, centrifugal, pumps,
Lobe), HVAC systems.
- Prior experience with GMP regulations
- Managing 10 people
- Reporting to the Israel General Manager
Maintenance Manager, Omrix Ltd.
Responsibilities:
- Responsibility over all the maintenance issues in Omrix new
plant in Jerusalem.
- Carrying out projects in the manufacturing systems, Utilities
and construction.
- Engineering designing.
Qualifications:
- B.Sc. in Mechanical Engineering/ electro-mechanics
- Technical English
- 5 years previous experience as a engineering manager in the
Pharmaceutical/food industry.
- Former knowledge in systems: water distillers, turbine systems,
biology production systems (UF, Colonas, centrifugal, pumps,
Lobe), HVAC systems.
- Prior experience with GMP
- Reporting to the Engineering Manager
Clinical Project Manager, Omrix Ltd.
Project manager to come in provides project management and leadership
to plan, prepare and execute one (or more) high quality clinical
project(s). Leads the clinical project toward completion of deliverables
in a timely fashion within an agreed project timeline. Internally
interfaces with data management, biostatistics, CRO, business
alliance leads, medical directors and functional management
Responsibilities:
- Responsible and accountable for one or more clinical trial(s).
- Responsible for ensuring the trial is "audit ready"
at all times.
- Leverages resources, expertise, and knowledge across multiple
projects to ensure attainment of project deliverables.
- Responsible for effective communication within the Clinical
Project Team and with functional management.
- Provides regularly updates regarding the status and progress
of the trials.
- Manages the project(s) within the approved budgets and timelines.
- Responsible for writing of clinical project deliverables such
as study manuals, study tools, operational plans, etc. within
the clinical project plan framework.
- Prepares investigational site lists and participates in reviewing
and approving investigational sites.
- Directs forecasting of devices necessary for project in collaboration
with supply-chain; reviews and approves various support system
specifications (e.g. IVRS, CRO, etc.).
- Supports the coordination and attends investigator and coordinator
meetings, representing the clinical project team.
- Provides oversight of individual clinical trials to ensure
that safety concerns and/or adverse events are identified and
appropriate responses to such concerns are developed and executed.
- Responsible for the identification of project risks and the
development and implementation of the mitigations for these
risks.
- Prepares and presents the status of the clinical project(s)
to the Clinical Affaires Manger.
- Responsible for corrective action plans across trial.
- Participate in internal/external trial-related audits.
- Demonstrates thorough knowledge of and coaches others in the
appropriate application of clinical research conduct, laws,
regulations, and standards, and compliance with applicable SOPs
and policies
Qualifications:
- Bachelor's-level degree in science/health related field (e.g.,
Biology, Biomedical)
- Preferred. 3-4 years experience in clinical research, or medical
devices/pharmaceutical clinical trials
- Coupled with the ability to manage projects and work with
clinical professionals within a team, as well as working in
a cross-functional product development setting.
- Reporting to the Clinical Trails Officer
Microbiologist, QC Laboratory
Qualifications:
- MS.c. Microbiology
- at least 3 years experience in QC labs in the Biotechnology
industry
- High level English
- Knowledge of GMP
- Proven track record in leading laboratory projects
- Ability to work non-standard hours
- Willingness to work at the new plant in Jerusalem in the next
year
- Candidate should be hard working, initiative and creative
person , independent and efficient Immunologist, QC Laboratory
Qualifications:
- At least 2 years experience in QC labs in the Biotechnology
industry or in a lab at a hospital.
- Previous experience in Elisa tests and in SDS-Page method
- Former knowledge in validation of methods
- High level English
- Candidate should be hard working, initiative and creative
person , independent and efficient
Deputy Manager, QC Laboratory
Responsibilities:
- Setting a list of priorities to all of the daily activities.
- Managing working teams
- Project managing in front of the R&D department
- Responsibility for the validation activities.
- Negotiations with suppliers for new laboratory equipment
- Preparing protocols for the Regulation department
Required Skills and Experience:
- MS.c/ PHD in Chemistry/Biology/Biotechnology
- Experience of 4 years in QC labs in the Biotechnology industry
- Managerial experience of 2+ years.
- Ability to work non-standard hours (including Fridays)
- Candidate should be hard working, initiative and creative
person , independent and efficient
Available openings in N.Y :
Available openings in EUR:
Regulatory Affairs Assistant
Required Skills and Experience:
- Background in one of the life-sciences
- proven track-record of at least 3 years of hands-on experience
in managing projects in Regulatory Affairs
- Considerable experience in biologics is essential and experience
with drug/device combination products as well as devices –
An advantage
- Knowledge and experience directly interfacing with the EU
auth orities on submissions and on advertising and promotional
reviews – An advantage
- Excellent interpersonal communication skills are essentials
- Good level of computer literacy
- Ability to make independent decisions with confidence
Responsibilities:
- Preparing and reviewing sections of EU dossiers, amendments
and supplements.
- Review of labels and promotional labeling
- Interaction with EU over submissions
- Working as part of an interdisciplinary team to develop and
implement regulatory strategies.
Available openings in Israel :
Clinical Trail Assistant
A project manager to provide management and leadership to plan,
prepare and execute one (or more) high quality clinical project(s).
Leads clinical projects towards completion of deliverables in
a timely fashion, within an agreed project timeline. Internally
interfaces with data management, biostatistics, CRO, business
alliance leads, medical directors and functional management
Education & Experience:
- Bachelor's-level degree required. Degree in science/health
related field (e.g., Biology, Biomedical) preferred.
- 3-4 years experience in clinical research, or medical devices/pharmaceutical
clinical trials
- 1-3 years experience managing projects and working with clinical
professionals within a team, as well as working in a cross-functional
product development setting.
Responsibilities:
- Responsible and accountable for one or more clinical trial(s).
- Responsible for ensuring the trial is "audit ready" at all
times.
- Leverages resources, expertise, and knowledge across multiple
projects to ensure attainment of project deliverables.
- Responsible for effective communication within the Clinical
Project Team and with functional management. Provides regularly
updates regarding the status and progress of the trials.
- Manages the project(s) within the approved budgets and timelines.
- Responsible for writing of clinical project deliverables such
as study manuals, study tools, operational plans, etc. within
the clinical project plan framework.
- Prepares investigational site lists and participates in reviewing
and approving investigational sites.
- Directs forecasting of devices necessary for project in collaboration
with supply-chain; reviews and approves various support system
specifications (e.g. IVRS, CRO, etc.).
- Supports the coordination and attends investigator and coordinator
meetings, representing the clinical project team.
- Provides oversight of individual clinical trials to ensure
that safety concerns and/or adverse events are identified and
appropriate responses to such concerns are developed and executed.
- Responsible for the identification of project risks and the
development and implementation of the mitigations for these
risks.
- Prepares and presents the status of the clinical project(s)
to the Clinical Affairs Manger.
- Responsible for corrective action plans across trial.
- Participate in internal/external trial-related audits.
- Demonstrates thorough knowledge of and coaches others in the
appropriate application of clinical research conduct, laws,
regulations, and standards, and compliance with applicable SOPs
and policies.
Deputy Manager, Regulatory Affairs, Israel
Required Skills and Experience:
- Ph.D. in Biochemistry / Biology
- Experience of at least 5 years in Regulatory Affairs
- Proven negotiation skills and significant experience in interacting
with regulatory authorities
- Established credibility with regulatory authorities
- Excellent knowledge of submitting RA files to health authorities
in the USA, Europe and Japan
- Excellent written and verbal communication, presentation,
and facilitation skills
- Strong & demonstrated people management
- Reporting directly to Regulatory and Clinical Affairs Director
- Ability to travel abroad as required
- English: Very high level / mother tongue -advantage
New Product Development Engineer
Job Description:
Will provide engineering support for research and product development
efforts for Omrix product portfolio such as medical devices and
critical systems
Required Skills and Experience:
- B.Sc. in Mechanical Engineering / Textile / Chemical engineering
- Experience of 4+ years in development and engineering support
for mechanical /plastic / textile products.
- Experience in the medical device industry – an advantage
- Creative thinking and good at technical problem solving
- Multitasking abilities
- Ability to manage and complete multiple assignments on time
- Good scientific writing, communication, and organization
skills
- Strong technical writing skills both in English and in Hebrew.
Responsibilities:
- Assist designing and promoting special engineering projects
- Research, develop, design and evaluate components, assemblies,
processes and/or equipment
- Actively participate in and contribute to design and develop
processes, including creating solutions, reporting on progress
in R&D meetings, design reviews, and
other applicable meetings
- Investigate and evaluate existing technologies
- Provide status updates to management as required
- Support the design process by writing test methods, specifications,
protocols and reports, and conducting testing on product
- Support product development in the following areas:
- Design products and prototype development
- Testing fixture design and fabrication
- Write and maintain ing detailed documentation throughout
all phases of research and development
- Prioritize own work – manage own work load
Mechanical Engineer, Israel
Required Skills and Experience:
- B.Sc. in Mechanical Engineering
- 2-4 years experience in engineering disciplines: instrumentation
and auditing (control), controlled machines, must possess knowledge
of related disciplines.
- Proven track record in pharmaceutical / biotechnology industry
- Self-motivated, good interpersonal skills, cap ability of
analyzing and solving complex
- problems through innovative thought and experience
- Ability to manage multiple tasks & initiate projects
- Ability to design and influence outside of immediate scope
of responsibility
- Ability to plan ahead and implement
- Candidate should be loyal, honest, initiative spirit &
a hard worker
- A team player yet work in liaison with other organizational
functions
Production Staff, Israel
Omrix seeks production workers willing to work in shifts including
weekends, if required.
Required Skills and Experience:
- Experience working in clean rooms – An advantage
- Candidate should show loyalty, honesty, be a team player
and esthetic
Send Resume to:
Please forward your resume, including job title, to: jobs@omrix.co.il.
All applications are treated as confidential. |
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