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We are seeking a Project Manager with a strong chemistry or technical regulatory background to support the operational, analytical, and cross‑functional activities of the Regulatory Affairs team.
In this role, the Project Manager will lead the planning, coordination, and execution of regulatory and cross‑departmental initiatives, ensuring alignment with organizational priorities and timelines. The position requires strong project management expertise and excellent communication skills. Responsibilities include coordinating team workflows, preparing project documentation and presentations, and facilitating effective collaboration with internal stakeholders, external partners, and regulatory service providers.
Key Responsibilities:
Lead material compliance projects, including planning and execution.
Develop, maintain, and monitor project plans, timelines, milestones, and deliverables.
Track team progress, ensure follow‑up on open items, and help remove obstacles.
Assist in annual and ongoing budget planning and management.
Coordinate and collaborate with R&D, Operations, Engineering, Legal, and other teams across the organization.
Monitor, interact, report, and provide support to local R&D and Engineering regarding compliance matters, enforcement actions, remedial activities, and regulatory requirements.
Manage global initiatives, ensuring alignment and effective utilization of cross‑functional resources.
Work with advisory services and manage regulatory subcontractors.
Assess local and regional compliance requirements and implement programs/systems to ensure regulatory compliance.
Gather strategic intelligence on evolving product regulations, advise management, and drive implementation of required compliance actions.
Generate or collect necessary documentation to support certifications and coordinate submissions to certifying laboratories/organizations.
Evaluate regulatory trends and revisions, and work with functional departments to proactively adjust processes to avoid certification disruptions.
Develop workflows, protocols, and tactical direction to support standardization and administration of product compliance programs.
Ensure all stakeholders are aligned and informed of progress, changes, and dependencies.
Prepare clear, professional presentations and reports for internal and external audiences.

We are seeking a highly motivated and qualified Analytical Chemist for a temporary maternity leave replacement position with a strong passion for laboratory work. As part of our CMC team, you will play a central role in the chemical characterization of our products by developing and implementing analytical methods to identify and quantify both known and novel plant-derived compounds.
You will work closely with multidisciplinary teams - including QA/QC, Regulatory Affairs, Tech, and Clinical - to support drug development activities and regulatory submissions, including FDA approval of inhalation technology.
Key Responsibilities:
Operate, maintain, and troubleshoot analytical instruments such as GC/MS, UPLC, and Karl Fischer titrators.
Perform routine and non-routine chemical analyses.
Develop, optimize, and validate analytical methods.
Write and execute protocols related to method development and validation.
Contribute to the preparation of regulatory documentation for drug development submissions.
Support ongoing and future research and development initiatives.
Collaborate effectively with cross-functional teams to advance project goals.

Required Advanced Manufacturing Engineer
Job Description Summary
Activities contributing to the design and development of products, solutions and systems. Includes activities linked to technical improvement of existing products and components Impacts quality of own work and the work of others on the team. Executes standard operational/technical tasks typically subject to instructions and work routines. There is latitude to rearrange the sequence to complete task/duties based on changing work situations.
Job Description
Key Responsibilities
Support the development, optimization, and control of manufacturing processes (e.g., lithography, etch, deposition, CMP, diffusion).
Monitor and analyze process performance, yield, and defectivity trends.
Perform root cause analysis and implement corrective actions for process deviations and excursions.
Collaborate with cross-functional teams (R&D, equipment engineering, quality) to improve process stability.
Assist in process qualification, technology transfer, and new product introduction (NPI).
Maintain and update process documentation, SOPs, and control plans.
Use statistical tools (SPC, DOE) to drive continuous improvement.
Support troubleshooting of equipment and process-related issues.
Ensure compliance with safety, cleanroom protocols, and quality standards.

In this fully onsite role, the Manufacturing Quality Engineer will own all qualiy activities at one of the manufacturing sub-contractors, support the validation process to the contract manufacturing and provide quality oversight to the engineering department, while working within a multi-functional team environment for medical devices. The Manufacturing Quality Engineer will lead projects and tasks, from product validation through transfer to the production and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. Additionally, this role will identify and implement improvements to the production processes. The Manufacturing Quality Engineer will be the products and production focal point for our sub-contractors and will be responsible for projects related to the production and machines, including training, audits, stop and renew the production.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that product and quality are held to the highest standard.
Work cross-functionally with individuals or extended teams to provide guidance and ensure success of projects.
Responsible to write, review and approve pilot documents (including reports).
Write and approve various department and production procedures and forms.
Lead investigation processes for deviations and nonconformities in production and create analysis reports.
Responsible to train the sub-contractors according to QA procedures and VoE.
Support special processes such as sorting or rework in production.
Own all production activities at one of the subcontractors to ensure manufacturing is held according to West procedures and GMP/GDP standards
Responsible for stopping and renewing production with accordance to West requirements and with MQ manager approval.
Manage production related projects and act as MQ focal point in various internal and external projects- such as Data Integrity, CoPQ, production improvement plans, etc.
Provide Quality oversight of validation activities and processes.
Lead pilot processes that include change and approval of quality aspects in pilot protocols and reports and assure that pilot processes are conducted according to West guidance and protocols.
Attend production pilot meetings as the MQ focal point.

Willingness to travel between sites located in Dimona and Beer Sheva

To operate within the production area, developing, implementing, and managing manufacturing methods, processes, and the sequence of operations.

To define process requirements, working procedures, and provide equipment recommendations for product lines.

To execute Process-FMEA analyses, identify possible sources of failures, and take measures to eliminate operational risks.

To define the process control methodologies and manage statistical process control systems to analyze out-of-control situations.

To liaise with Quality Assurance in responding to customer inquiries, and with Design Engineers to coordinate the launch of new products.

To monitor functional-specific trends and derive recommendations for their (incremental) improvements.

To execute focused research, create informative reports to support change or adaptation for processes and infrastructure systems.

To contribute to projects or processes to improve functional efficiency and effectiveness.

To take over the accomplishment of dedicated (local or function-specific) workstream, as part of an overarching infrastructure project.

Monitor and improve production processes in line with product specifications and quality standards.

To identify and analyze process issues and recommend improvements to increase efficiency and reduce waste.

To create and maintain production documentation, such as standard operating procedures and work instructions.

To collaborate with other departments, such as Manufacturing, Quality Assurance, and Research and Development, to ensure smooth production processes.

Identify opportunities for improvement and implement solutions.

To train and mentor production and maintenance teams on new processes and equipment.

Run engineering experiments to qualify new process, raw materials and equipment

Perform statistical analysis for change validation