תוצאות חיפוש - Omrix Biopharmaceuticals

In this role you will perform technical work, including: design, implementation, operation and improvement of utilities and critical utilities, systems and equipment within the manufacturing processes.
We are looking for someone that:
• Manage projects and continuous improvement initiatives.
• Maintaining all required safety, quality, and compliance requirements.
• Develop future upgrades road map creation including exploration and assessment of new technologies and industry's best standard methodologies.
• Handling a project portfolio and assigning tasks according to the projects scope, this includes financial planning and follow up against execution schedule while finding the accurate mitigations for expense gaps.
• Responsible for the operation and maintenance of the systems in scope.
• Communicating with internal and external partners.

Ethicon, Inc., is recruiting for a Regulatory Affairs Specialist, CMC for the Ethicon Biosurgery Franchise. The position will focus on biologic products, drug products, and drug-device combination products and may be based at any J&J site. Preferred locations are the J&J sites located at Ness Ziona, Israel or Raritan, New Jersey, United States. Other global J&J locations and remote work options may be considered on a case-by-case basis and if approved by the Company.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Regulatory Affairs Specialist, CMC for Ethicon’s Biosurgery business unit will be the Regulatory lead on significant manufacturing change projects, including manufacturing line scale-up, material and component replacements, and manufacturing site transfers, for the Ethicon Biosurgery drug and biologic portfolio. The Regulatory lead will partner with R&D, Technical Operations, Supply Chain, and other cross-functional team members to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through project team support, audit support, excellence in submission execution, and global health authority interactions.

The products supported by this position are regulated worldwide as biologics, drugs, or high-risk medical device (combination products) which are intended to address a range of surgical challenges related to bleeding and sealing. Primary responsibilities will include:

Key Responsibilities:
• Represent Regulatory Affairs on cross-functional project teams by providing robust global regulatory impact assessments and reviewing and providing feedback on project documentation.
• Research, draft, circulate for cross-functional review and approval, and submit global regulatory affairs submissions. This role will be responsible for submissions directly to the United States Food and Drug Administration, European Medicines Agency, and Israel Ministry of Health. Other markets will require interaction with J&J Affiliate Regulatory Affairs to coordinate submission activities.
• Clear, accurate, and timely communication with project team members, stakeholders, and management about regulatory requirements, submission deliverables, timelines, and risks.
• Clearly and timely communicate compliance issues to Regulatory Management that could affect registration or regulatory compliance.
• Active role on project teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
• Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
• Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled and compliant.
• Interact with Health Authorities in key markets regarding product regulatory filings.
• Develop deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for life-cycle management of products.
• Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.
• Assist with front-room and back-room regulatory activities associated with internal and external audits.
• Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.

We at Omrix Biosurgery Israel are seeking for a strong Business Excellent lead both sites. Reporting to the Business Excellences & Strategic programs Sr. Manager. In this role you will, lead routine optimization in cost, quality and service in routine activities and the development, recommendation, and implementation of projects.
Leading development and implementation of organizational metrics and reports.
Applies management routines to ensure efficient work and waste reduction.
Job Summary:

o Reviews and analyzes complex projects and studies involving process or product costs, process control, or other labor related issues.
o Lead JJPS implementation with in the sites.
o Interprets labor standards by conducting time studies and evaluating methods used in fabrication and assembly areas and inputting data into labor models.
o Applies statistical methods and performs mathematical calculations to determine manufacturing processes, staff requirements, and production standards.
o Implements and communicates changes to methods for improving worker efficiency and reducing waste of materials and utilities such as restructuring job duties, reorganizing workflow, relocating workstations or equipment.

QE for External OPS (reporting to QA lead)

Scope:
Quality engineer for external manufacturing and IVIG

Responsibilities:

This role combines 2 major aspects - IVIG release and LYO release including communication with EX-OPS suppliers.
- Full responsibility for EVICEL final release for ROW and IVIG release
- Approval of shipments (preparation and final after shipment)
- Support packaging department and visual inspections - write assessments, review investigations and release WS's
- Release protocols and contact with authorities before final release
- Works closely with planning department and ETHICON affiliates in the world in order to meet business needs and release on time
- Back up in 2022 and full responsibility in 2023 for all EX-OPS activities – release LYO batches (batch files review, issue CoA's, CoC's, CBER), responsibility on Grifols, Patheon and Ferrosan tasks (assessments, change controls, protocols, and development)

We at Omrix Biosurgery Israel are seeking for a strong Supply Chain Planner for our Nes Ziona site. Reporting to the Planning Manager . In this role you will be part of the site Leadership team, responsible for all PLAN actives to ensure timely delivery finished products. Be core member in strategic projects lead cost improvement project.
Job Summary:
• Production planning– weekly plans, long term plans, capacity assessment, scenario planning
• Coordinate cross function activities for all operation and support departments to ensure max utilization of the site, follow up on execution
• Support site manager in decision making process to support service and financial goals
• Plans and controls inventory of finished goods to meet sales and distribution demand
• Lead Supply Chain improvement projects to optimize the Planning activities

The Ethicon business, within the Med Tech sector, is recruiting for a Finance Director supporting its Biosurgery Business

This critical position supports the growing Biosurgery business and is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. We are proud to be an equal opportunity employer.

Scope of Responsibilities:

This role reports to the Senior Director Ethicon/CSS Supply Chain and will provide financial and business leadership to drive both the short-and long-term strategies for the Biosurgery End to End Supply Chain business. Additionally, you will provide direct business partner support to the Biosurgery E2E SC Lead and will be a member of the Biosurgery SC Leadership team. This position is key to enhancing value within the supply chain, managing a high degree of complexity within demand/supply, ensuring quality, and making the very best decisions across a diverse network of internal and external manufacturing to support the growth agenda for Biosurgery.

Key Activities for this position include but are not limited to:

Lead a diverse team of ~20 + associates (including 3 Managers) located in 3 manufacturing sites based in Israel, China and Switzerland with dotted lines to multiple facilities and stakeholders.
• Develop, adjust, implement and maintain organizational design that supports the global Biosurgery business
• Develop functional goals and objectives
• Provide an environment for professional growth of staff which includes concrete feedback, recognition and rewards
• Provide coaching and mentoring in support of the staff’s development plan

Provide leadership to the Biosurgery SC business and commercial teams supporting $1.6B of sales and over $0.4B in COGS
• Decision making & funding prioritization
• Supply Chain related insights to drive key Strategic Initiatives and current year plans
• Lead consolidations and analysis on both a forecast and actual basis to understand main drivers of costs and highlight cost improvement opportunities.
• Partner with Ethicon to deliver Strategic imperatives
• Drive value creation through cost improvement initiatives, capital investment decisions, product portfolio and asset reconfiguration activities.

Deliver simplicity and agility for planning and reporting, drive effectiveness in the control environment
• Ensuring SOX controls and compliance standards are fully met for all processes
• Support the Senior Director in various adhoc analysis and coordination of financial requirements,
• Participate in various JJSC Finance initiatives (e.g. Credo initiatives, process improvements, etc)
• Drive increased value creation through new product launches
• Perform external and internal benchmarking to enhance value

Overall accountability to lead operations and delivery commitment of the manufacturing site . This includes responsibility over the Operation readiness and excellence of execution in the plant in regards to: Safety, Quality, Line items delivery, WF planning and development,planning and execution of strategic road map. Member of Biosurgery Israel leadership team.
The Business Unit Manager has accountability for executing network strategies and for delivering results across a substantial global dashboard of metrics with a large number of stakeholders. This will require project prioritization, resource optimization, global project collaboration, influence, and implementation of projects and programs to drive results that will maximize value to the customer and the business. Particular emphasis will be on valuing people as a key enabler to creating a culture of engagement. He/she collaborates with a significant network of global stakeholders across functions such as Quality, Engineering, Production Planning & Logistics, Finance, HR, Procurement, R&D, Marketing, and key stakeholders in the Franchise structure.
Reporting to Biosurgery MAKE Lead and Israel GM..

Duties & Responsibilities:
• Sets manufacturing objectives in alignment with business and plant objectives.
• Responsible for leading the production teams, people development, and overall employees’ development cycle
• Overall responsibility for execution of supply plans with alignment to market demand (S&OP) both short and long term
• Ensures all manufacturing processes are executed in safe and compliant manner to meet production plan rates and targets.
• Preparation and managing of annual budgets and strategic plans, including headcount predictions, operating expense and capital requirements
• Constantly evaluates operations to simplify the value stream, reduce scrap and cycle times, and enhance margins. Through empowerment and engagement of others, relentlessly drives continuous improvement in all aspects of the dashboard. Uses lean and process excellence principles and tools as appropriate. Reviews, evaluates, leverages and adapts new technologies.
• Accountable for executing network strategies and for delivering results across a substantial global dashboard of metrics with a large number of stakeholders.
• Managing and governing capital budgets, improvements projects at the manufacturing site. Ensuring meeting all projects commitments (budget, schedule, uality, other defined KPIs, etc. )
• Leading the manufacturing site safety culture and behaviors. Ensure risk mitigation program are in place. Accountable for compliance with local and JNJ EHS requirements.
• Lead and develop the manufacturing site cross functional leadership team.

Quality and Compliance Related Responsibilities:
• Ensure appropriate quality systems in place
• Evaluates effectiveness of CAPAs and FIs to ensure root cause of non-conformances is eradicated and continuous improvement achieved.
• Ensures that technical support activities are carried out in compliance with all regulations and laws governing business and quality operations (QSR/GMP, ISO, etc.).
• Responsible for ensuring staff and company compliance with all local, national, international and company regulations, policies and procedures for EHS.
• Operational responsibility in CC/CAPA approval cycles

We at Omrix Biosurgery Israel are Looking for a Finance Manager to lead our finance department. The position is based in Nes Ziona, Israel and will report to the Biosurgery SC Finance Director. Omrix Biopharmaceuticals is part of J&J Biosurgery Supply Chain and produces Plasma derived Biologic products distributed by J&J Worldwide.

Scope of Responsibilities:

A key business partner and member of the Omrix Plant leadership team while collaborating with several internal, cross-country & external partners.

You will be responsible for crafting and delivering insight and actions to increase production value of biological products produced at Omrix, by delivering data analysis & insights while partnering with Plant Leadership to drive efficiencies.

You will lead the Omrix Finance department including, FP&A, Accounting and Controlling and have responsibility for full P&L/BS/CF including US GAAP reporting to J&J Corporate and SOX controls.

You will support the Biosurgery SC Finance Director in various projects, including A&D, Value Streams, Transformation etc.

MAIN TASKS:

• Business Unit Finance Partner to the Omrix GM and Plant Leadership
• Lead a finance team of over 10 people including FP&A and Accounting
• Own the financial planning encompassing the preparation, consolidation and review of the detailed financial analysis
• Actively influence well-informed decision-making through financial analysis and insights
• Set objectives, actions & follow-up to promote a cost control through encouraging the Business Unit to adopt improved processes & performing detailed cost monitoring.
• Statutory reporting including tax reporting collaborating with J&J Tax CTC
• SOX and Compliance-related activities and responsibilities
• Drive accountability and ensure compliance with the J&J WWP
• Should possess sophisticated business intuition, including the passion to develop business cases and implement strategies as well as the ability to think about the broader J&J business implications, lead through ambiguity and make difficult decisions

Quality specialist for packaging and External OPS (reporting to QA lead)

Scope:
In charge on quality aspects in packaging department and back up for external operations:
- Full responsibility on quality aspects in packaging department:
• Work on daily basis with production manager and packaging line team leader
• Perform tours and inspections on packaging department
• Perform risk assessment for NC's
• Review investigations, CAPA's, change controls
• Review visual inspections worksheets and packaging worksheets
- Back up to LYO release (batch files review, issue CoA's, CoC's, CBER, shipment documents)
- Temporary position for 8 months(until may at least)

The Engineering team leader - Utilities will:
Provide Leadership and direction to a team of engineers and validation engineers to drive qualitative and continuous improvement, Problem solving and project management while maintaining all required safety, quality and compliance requirements in the field of utilities and critical utilities.
Chairing the technical execution of projects, communicating with internal and external partners. Handling a project portfolio and assigning tasks according to the projected scopes. This includes financial planning and follow up against execution schedule while finding the accurate mitigations for expense gaps.
Develop future upgrades road map creation including exploration and assessment of new technologies and industry's best standard methodologies
Responsible for the operation and maintenance of: Water system (Reverse Osmosis, WFI Stills, Waste neutralization), compressed Air, Clean-In-Place systems.

• Full time employee, as part of the Omrix Change Admin Team
• Provide Quality Systems support for Document and Change Controls in Windchill Data Management System
• Training/Assisting Omrix users in using Windchill System
• Controlled Printing of Production Worksheets
• Support for Internal and External Audits

Ethicon, Inc., is recruiting for an Associate Director, Global Regulatory Affairs, CMC for the Ethicon Biosurgery Franchise. The position will focus on biologic products, drug products, and drug-device combination products and may be based at any J&J site. Preferred locations are the J&J sites located at Ness Ziona, Israel or Raritan, New Jersey, United States. Other J&J locations throughout the U.S. and Europe will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Associate Director, Global Regulatory Affairs, CMC for Ethicon’s Biosurgery business unit will be responsible for leading a team of Regulatory professionals and partnering with R&D, Supply Chain, and other cross-functional team members and leaders to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through strategy development, excellence in submission execution, global health authority interactions, internal and external policy shaping, and growing and developing talent.

The products supported by this position are regulated worldwide as biologics, drugs, or high-risk medical device (combination products) which are intended to address a range of surgical challenges related to bleeding and sealing. Primary responsibilities will include:

Key Responsibilities:
• Lead, inspire, motivate, and manage a team of Regulatory CMC professionals to obtain and maintain market access for Chemistry, Manufacturing, and Controls (CMC) related changes to Ethicon Biosurgery biologic, drug, and combination products. (Currently this position has 3 direct reports (2 permanent staff, 1 contract staff) and responsibility for an overall team of 12 individuals, including both permanent and contract staffing).
• Mentor, coach, train, and develop technical and professional skills of the Regulatory CMC team.
• Maintain up-to-date understanding of global biologic, drug, and combination product regulations and guidance documents and advise Regulatory Affairs team and internal stakeholders on the interpretation and application of health authority expectations.
• Oversee assessment and communication of global CMC changes, strategies, risks, and requirements to internal business partners and leadership teams.
• Clearly and timely communicate compliance issues to Regulatory Management and business leadership that could affect registration or regulatory compliance.
• Active role on various leadership teams, including Ethicon Biosurgery Regulatory leadership team and Supply Chain leadership teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
• Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
• Partner with regional Regulatory leaders on regulatory strategy and submissions to successfully obtain and maintain marketing approvals for all other markets.
• Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled and compliant.
• Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.
• Partner with regional leaders and the Regulatory Affairs Policy Intelligence team to monitor the regulatory environment globally and assess and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking.
• Evaluate the impact of current and emerging standards and regulations, assess the most effective and efficient strategies for obtaining or maintaining product registrations globally, and communicate changes and impact to cross-functional business partners.
• Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
• Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.
• Collaborate with Quality partners regarding product non-conformance and quality issues by contributing to internal investigation and risk management reviews.
• Manage, oversee, and balance resource allocation and budget across critical projects.
• Influence and collaborate to bring about process and technical improvements within the organization.
• Represent the company and influence regulations and health authority guidance through industry trade association(s) in partnership with the Policy Intelligence team.
• Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.

Omrix Biopharmaceuticals, a Johnson & Johnson Company, is looking for a vital, dynamic, and reliable Assistant Controller

Main Responsibilities:
• Preparation of the statutory financial statements and tax return
• Taking part in the monthly and quarterly reporting in accordance with US GAAP
• Work closely with the Company's external auditors during financial and tax audits
• Responsible for tax reporting, collaborating with J&J Tax Corporate
• Leading SOX compliance and ensure proper implantation control processes
• Lease accounting calculations
• Ad-Hoc accounting and finance-related projects as needed