External Manufacturing Resume Sample
Vivianne Wiegand
64563 Kulas Spur,
Boston,
MA
+1 (555) 380 0550
Work Experience
Associate Director, External Manufacturing
01/2018
-
PRESENT
Los Angeles, CA
- Category Scope – Direct responsibility for a portfolio of categories and supplier relationships that are Global or International in nature. Indirectly responsible for Local and Regional categories. In collaboration with stakeholders and Regional procurement professionals, creates and implements 1-3-5 year strategic sourcing strategies
- Managing all product supply aspects that a Third Party provides (new product launches, business planning, budgeting, procurement of components/raw materials, project management, equipment and packaging engineering, product quality, adherence to the appropriate GMP’s (food, drug and/or dietary supplement) and non-conformance elimination)
- Behave as equal business partners, communicating to business leaders and peer functions, highlighting conflicts, options, priorities and rationale, as necessary
- Provide inspirational communication to team members; identifying the priorities, expectations, and rationale behind change initiatives
- Conduct regular category reviews for assigned sources to assess progress vs. plans, adjusting as required to deliver mitted results
- Drive the delivery of fundamental supply execution in compliance, service, quality, innovation, and cost management
- Challenge plans for sufficient stretch, helping to identify barriers, requesting support as needed
- Normally 10-15 years’ experience including mill and cross functional staff positions
- Demonstrated knowledge of business unit brands, manufacturing techniques, market strategies, and extensive experience in managing a complex category
Q&FS External Manufacturing Technologist
08/2011
-
08/2017
Dallas, TX
- Planning Support: Forecasting, S&OP and Purchase Order processes with our key External Partners
- Logistics Support: Goods Issue/Receipt, Import/Export, Cold Chain Management, Trade Compliance, Shipment Tracking, Duty Drawbacks, etc
- Supply chain aspects of projects, including source changes, new CMO integration, product launches, etc
- Supports ExM Profit Plan, Inventory Planning, Inventory Reconciliation and IQV processes
- Supports World Class Supplier processes of Issue Management, Horizontal Tier, Event Management to proactively identify, mitigate, manage and prevent supply issues
- Responsible for customer service metrics for ExM. Evaluates root cause, lost opportunity and drives for continuous improvement
- Robust processes to drive and maintain SAP Master Data Accuracy
Intern External Manufacturing
06/2007
-
02/2011
Phoenix, AZ
- Experience working with the business unit to develop, engage, and lead strategies and projects
- Proven leadership in achieving cost transformation targets
- Experience as a thought leader demonstrating ability to influence others including senior leaders
- Led and successfully delivered on multi-disciplined, cross functional projects
- Preference for adult incontinence, feminine care, baby diapers, or other absorbent hygienic industry experience
- Vendor management and relationship management experience
- To achieve World Class Supplier (WCS) level performances, the Ops AD shall be able to drive global competitiveness on cost and lead-time with 100% compliance for each of the EP s/he manages
- The Ops AD shall serve as “Virtual Plant Manager” for key EPs to achieve in-depth understanding of the EPs’ systems, capabilities and capacity utilization, and to be actively engaged in the EPs’ operations to ensure reliability of MSD supply chain
- The Ops AD is the primary owner of MMD’s relationship with the EP and the point of contact for all interactions between the two parties. S/he shall serve as the air traffic controller for all information exchanges between MMD and EPs and shall establish boundaries and rules of engagement
Education
Missouri University of Science and Technology
2003 - 2007
Bachelor's Degree in Engineering
Professional Skills
- Excellent analytical and computer skills, including software packages used in the maintenance and analysis of data is required
- Direct experience in the writing/reviewing of Master Validation Plans, Protocols, and Reports
- Experience working with external manufacturing partners
- MASTERY: Good technical knowledge, ideally plant operations or planning experience is desirable
- Strong interest in plant operations or technical packaging development
- Experience with external manufacturing partners
- Experience working with regulatory agencies (FDA, EPA, OSHA)
How to write External Manufacturing Resume
External Manufacturing role is responsible for analytical, english, software, building, negotiation, leadership, analysis, finance, training, integration.
To write great resume for external manufacturing job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For External Manufacturing Resume
The section contact information is important in your external manufacturing resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your External Manufacturing Resume
The section work experience is an essential part of your external manufacturing resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous external manufacturing responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular external manufacturing position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative External Manufacturing resume experience can include:
- Knowledge and track record of managing technical team, good problem solving capability, and driving for success across multi-sites / functional teams
- Experienced in working with Contract Manufacturing Organizations to manufacture clinical and commercial parenteral products
- Experience in strategic sourcing, market/sell, supply chain or other commercial roles is required
- Support quality audit at external manufacturing sites, or qualification process audit prior to production release as part of pre-production preparation
- In-depth and hands-on experience in assembly packaging, process integration, technology transfer and qualification activities
- LEADERSHIP: Energize and Engages Contractors and Supplier to identify and delivery common goals – focusing on priorities to overcome any challenge
Education on an External Manufacturing Resume
Make sure to make education a priority on your external manufacturing resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your external manufacturing experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in External Manufacturing Resume
When listing skills on your external manufacturing resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical external manufacturing skills:
- Strong relationship building skills demonstrated both internally and externally
- Strong analytical and presentation skills with proven decision-making capabilities
- Good communication skills both in written and oral form
- Strong leadership and people skills, adapts well to a fast paced and open culture
- Excellent organization, project management and communication (presentation and writing) skills
- Knowledge of Good Manufacturing Practices applicable to pharmaceutical solid dosage forms (tablets and capsules)
List of Typical Experience For an External Manufacturing Resume
1
Experience For Associate Director, External Manufacturing Resume
- Demonstrated ability to function in a matrix and a collaborative team-oriented environment while embracing and driving change
- Provide mentoring and staff career development. Foster good communication and team work among staff. Encourage personal growth
- Demonstrated ability to see beyond own function to understand business issues and implement best practices
- Experience with SAP based MRP platform and Track wise change control and customer complaint applications
- Lead CMO relationships and foster collaborative partnership including ensuring fulfillment of agreed manufacturing services for clinical and commercial supply
- Recommend and implement a supplier integration portal that allows Pinnacle to communicate needs and timing to External Manufacturing Partners
- Be the Operation contact window in Transfer or NPD project environment. Leading assembly/test team as the Technical Lead from external manufacturing
- EM Site Compliance, EHSS, Q&C, Customer Service, Cost metrics
2
Experience For Q&FS External Manufacturing Technologist Resume
- Continuous Improvement results (via LEAN & 6-Sigma)
- New Product Introduction, On-time delivery
- Coordinated all project activities with CMO PM’s and/or business partner manufacturing sites, including but not limited to: identifying and agreeing all technical deliverables, tracking of outputs and project step completion times, and providing any required associated reports
- Lead the sourcing strategy development by having clear understanding of the business needs from the key stakeholders, with the in-depth knowledge about Supply Base Industry (capabilities, strengths, weaknesses), then translating this into aligned strategies that drive end to end value including cost, quality, supply reliability and agility
- Working knowledge of GMP manufacturing processes
3
Experience For Assoc Dir External Manufacturing Resume
- Issue indirect purchase orders onto CMO’s for miscellaneous expenses and charge to appropriate P&L
- Act as primary BEM supply chain contact for internal and external customers for product inquiry, supplier performance, shipments, scheduling, and transactional activities and providing supply chain support for assigned products and CMO’s
- Conduct Request For Information (RFI) and Request for Proposal (RFP) utilizing Dow’s electronic sourcing tools
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck/MSD and compliance with all governing regulations; review and approve changes to master batch records
- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
- Provide support for audits of EP/ExP by Merck/MSD and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
- Conduct routine analytical change requests and support process modification change controls
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
- Support routine process validation; review and approve validation reports/tech transfer
4
Experience For Director External Manufacturing Resume
- Track and monitor operational and quality performance of the external manufacturer/partner
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine
- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes
- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums
- Ensure timely and accurate batch management in Oracle R12 (following the required CMO lead times) beginning with batch creation and progressing through to batch release, step execution, and ultimately batch closure
5
Experience For Associate Director External Manufacturing Virtual Plant Manager Resume
- Ensure purchase orders are created and sent to CMOs in time to reserve their capacity for the requested production slots, and approve the related invoices upon production completion
- Enter transport requests into Oracle R12 and collaborate with Logistics to ensure timely delivery to and from the CMOs, 3PLs, and internal sites, as required
- Monitor and evaluate KPI metrics to measure CMO performance
- Support the Business Process Owner and the global alignment of standard practices
- In conjunction with the broader Supply Chain organization, match supplier capacity and capabilities to the short, medium and long term demand planning process for the company
- Communicate the production needs to key suppliers, ensuring material and capacity are available to meet the needs of the company and deliver 99% + customer service
- In conjunction with the Continuous Improvement team, design and implement the most efficient production calendar allowing the supplier to maximize production and deliver greater levels of productivity for the company
- Make formula based recommendations for Days of Stock for raw materials and finished goods to enable 99% Service levels
- Drive Cost savings ideation sessions at the suppliers, identify plan of activities and actions; and track improvements. Work with procurement team to deliver savings on the contract
6
Experience For Senior Manager, External Manufacturing Resume
- Collaborate pro-actively with the innovation team to establish the supply chain processes, trials, feasibility and start up visits, learning curves, production schedule, communication cadence, KPI’s and ways of working with Suppliers for new product launch and delivery
- Aseptic Parenteral Filling operations or development experience
- Lead or participate in projects including process optimization or improvements, new technology introduction, new component introduction or material changes
- Oversees the compilation, analysis and reporting of associated metrics for deviations, CAPA and change control
- Maintain and provide expertise on BQOEM systems, tools, data, and processes on an ongoing basis
- Coordinate and facilitate systems training (i.e. GCM Trackwise, COMET SAP)
7
Experience For External Manufacturing Sourcing Specialist Resume
- Monitors the compliance of BQOEM and supporting functions to requirements of the deviation management, CAPA management and change control processes
- Responsible, as needed, for serving on teams when Quality representation is required related to any systems, data, or processes
- Provide leadership to the small molecule external manufacturing team to ensure alignment with Corporate and Technical Operation goals
- Work with the support groups to complete process changes, deviations and risk assessments and other compliance activities as required
- Project management (PMP or equivalent) qualification preferable
8
Experience For Director, External Manufacturing Sourcing Resume
- Directs the development, implementation, maintenance, and enhancement of critical processes and systems
- Functions independently and exercises a leadership role to enhance existing business processes and systems and to identify and advance performance improvement activities
- Acts as the primary contact for relevant functional areas on change request documentation requirements to provide real-time, proactive advice and guidance
- Escalates identified risks in the associated business processes to the appropriate management forums
- Lead a group of manufacturing managers/technical staff to develop and maintain a world class operation in support of SGEN commercial and clinical small molecule contract manufacturing
- Negotiate complex clinical and commercial supply and service agreements with Contract manufacturers
- Support late stage commercialization activities including PPQ planning, risk identification and management and execution and PAI preparation at small molecule CMOs
- Support global CMC regulatory filings in accordance with applicable regulations and guidance
9
Experience For Senior Manager External Manufacturing Make Resume
- Establish strategic approach to small molecule and raw material sourcing including CMO identification, selection and strategic fit to Seattle Genetics business needs
- Build effective partnerships with internal partners including Process sciences, Quality, Regulatory, and CMC Strategy to ensure alignment on supply goals, project timing and quality expectations
- Key member of global manufacturing and global regulatory compliance teams
- Support technology transfer at contract manufacturing organizations as required and cultivate productive working relationship with external manufacturing partners
- Demonstrated Track record of successfully leading high performing manufacturing group(s) and/or technical team(s)
10
Experience For Director External Manufacturing Technical Operations Resume
- Drive performance management and continuous improvement
- Deep knowledge of small molecule API synthesis and at scale GMP production required
- Familiarity with US and international regulatory and quality guidelines for pharmaceutical industry
- Accountable for the planning, leading and coordinating activities involved in the design/development, implementation and governance of a harmonized Quality Management System (QMS) program including Quality policies, standards, and procedures
- Ensuring that Merck has a cGMP compliant and cost efficient QMS system fully integrated into global and site business processes and continuously improved through Quality subject matter expertise
- Providing leadership, QMS expertise and facilitation of strategies for complex or cross-site/ cross-product quality system remediation efforts for Merck sites and products, including external manufacturing partners
List of Typical Skills For an External Manufacturing Resume
1
Skills For Associate Director, External Manufacturing Resume
- Effectively develop and deliver employee training on Quality Management Systems and related Quality Manual documents
- Prior management experience is required
- Effectively influence and drive consensus across Global cross functional teams and can interact with all levels of management
- Experience managing Global teams and engaging with Global business partners
- Strong working knowledge of COMET SAP (for deviation & CAPA management and batch disposition )
- Strong working knowledge of GCM Trackwise and change control processes
- Demonstrated situational leadership and problem solving within teams
2
Skills For Q&FS External Manufacturing Technologist Resume
- Strong business acumen (understanding of inventory reconciliation, budget, and spend allocation)
- Five years combined experience in a packaging environment (operations, project management, quality, technology, or supply chain)
- Experience with small scale cell culture or viral manufacturing desired
- Strong Process Improvement knowledge like Lean Sigma, MPS, among others
- Experience with Quality Risk Management
- Quality experience with Biologics or Therapeutic Proteins
- Strong Process Improvement knowledge like Lean Sigma, MPS, etc
- Demonstrated ability to manage and improve processes and to drive change
- Experience in multiple business areas – operations, supply chain, procurement
3
Skills For Assoc Dir External Manufacturing Resume
- Experience with biologic and/or vaccine Quality Assurance and Quality Control preferable
- Experience with SAP based MRP platform and Trackwise change control and customer complaint applications
- More than 10 years’ experience in the field of medical devices or combination products development and commercialization is required
- Strong business acumen and ability to manage multiple projects
- Working knowledge of aseptic manufacturing processes
- Willing to travel up to 10% of the time within and/or outside Puerto Rico
- Willing to work off-hours, when needed
- Having great knowledge of suppliers, their industries, products, services, business context within their scope
- Responsible for all aspects of managing the drug product manufacturing and packaging, inclusive of managing the sourcing and supply of API
4
Skills For Director External Manufacturing Resume
- Visiting CMOs/CPOs, attending conferences, attending training
- Sharing MSD’s Maufacturing objectives for the relationship with the contract manufacturers they manage & gaining alignment to these objectives with the contract manufacturers in a collaborative & professional manner
- Developing and executing technical transfers including training the EM team and CMO’s teams in the new processes
- Prepare, support, and / or manage processes requiring executive level presentations regarding drug product manufacturing to drive manufacturing decisions
- Knowledge of SOx controls and GAAP accounting principles especially manufacturing accounting
- Talent Development of Team, to include Development Plans, Target Job Mapping, Coaching of Team, HIPOs,
- Act as a key senior level External Manufacturing representative on joint governance committees with strategic manufacturing partners
5
Skills For Associate Director External Manufacturing Virtual Plant Manager Resume
- Act as Project Leader for GMP production at Contract Manufacturing Organizations (CMO)
- Ensure externally manufactured products are produced and stored according to the appropriate documentation in order to obtain the required quality
- Approve instructions relating to external production operations and ensure their strict implementation by the CMOs
- In collaboration with Quality and Technical Development coordinate investigations and troubleshooting efforts at CMOs
- Global Surgery External Manufacturing Leadership Team
- Manage a budget up to ca $50 M ensuring all PO’s are actioned in a timely compliant manner
- Serves as a senior leader on the External Manufacturing Leadership Team
- Oversee repackaging activities in the ExP/EP
- Stability Program management, including review of stability reports, and Annual Product Review assembly
6
Skills For Senior Manager, External Manufacturing Resume
- Initiate and manage change controls in Agile PLM to support the external manufacturing team
- Manage the current supply base to achieve all current business objectives as well as define a 5 year strategy and plan for execution
- Incorporate the standard metrics of: Quality and Compliance, Lowest Total Cost, Responsiveness, and Continuous Improvement as the company progresses the commercial operations
- Pharmaceutical and Medical Device experience, with extensive knowledge of development practices, manufacturing processes (liquid suspension, nasal products ideal), and all relevant GXP standards and guidelines
- Manage of CMO organizations including contract negotiations, achieving quality standards, continuity of supply and business continuity
7
Skills For External Manufacturing Sourcing Specialist Resume
- Accountable for Engineering (STR) forecast sharing and capacity commit process with 3PF/Subcon
- Create budgets (expense and capital) and to project and manage BVA and PPV
- Identify and resolve capacity disconnects. Show leadership to get to results
- Develops long-term external manufacturing plans consistent with the Company's strategic plans and objectives. Identifies manufacturing constraints and develops means to anticipate and alleviate them
- Travel required:Occasional, as required (10-20%)
- Overnight absences required. Occasional, as required
- Act as a single point-of-contact to the CMOs to ensure on-time and in-full deliveries. Partner with supply chain, quality and technical development on all aspects of the relationships with the CMOs
- Overall accountable to ensure all operational related activities at the CMOs are conducted to meet Moderna’s requirements (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx)
8
Skills For Director, External Manufacturing Sourcing Resume
- Maintain the integrity of the Master Supply Agreement ensuring alignment with Quality agreements and appropriate documents. Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries
- Ensure in collaboration with quality and technical development that the appropriate qualification, maintenance, trainings and validations are performed to meet the appropriate Moderna’s requirements
- Coordinate and perform the reviews for process performance at CMOs
- Monitor Key Performance Indicators of CMOs
- Support preparation of periodic business and operations review meetings
9
Skills For Senior Manager External Manufacturing Make Resume
- Drive and implement agreed continuous improvements at CMOs
- Coordinate reviews and approvals of various documentations from CMOs
- Write or revise the appropriate GMP documentations
- Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationship with the Project Management Counterparts in order to assess the as is state & risks for action-oriented improvement plans
- Education desired: BS - Business, Finance, or Engineering
10
Skills For Director External Manufacturing Technical Operations Resume
- Review and understand the strategic business unit’s business plans considering supply implications through regular participation in cross functional product projects
- The ExM VPM is responsible for all operational related activities including but not limited to:
- Be an engaged business partner through regular reviews of regional and global innovation plans within categories of accountability
- Sharing Manufacturing Division’s objectives for the relationship with the contract manufacturers they manage & gaining alignment to these objectives with the contract manufacturers in an inclusive & professional manner
- Experience in the pharmaceutical industry
- Proficiency in EnglishContract Manufacturing
List of Typical Responsibilities For an External Manufacturing Resume
1
Responsibilities For Associate Director, External Manufacturing Resume
- Partnering with stakeholders and customers at internal and external sites to ensure alignment of Quality systems throughout the Merck internal network and across the standards and procedures used by Merck and our external manufacturing partners
- Excellent interpersonal and communication (oral/written) skills
- Strong in technical project management, yield and statistical process control, package final test analysis methods, and failure analysis techniques
- Multi-country and multi-sector experience
- Fluency in English and excellent written communication to enable proper documentation and technical discussions
- Map existing processes used by the EM/PSSD Organization and develop new processes to manage documentation,
- Implementation of business processes for integration of QMS management into relevant elements of Merck’s internal site and external network operations
- Deploying the QMS Training Program and developing and training personnel, including internal stakeholders and customers, as well as external manufacturing partners on redesigned Quality Management Systems
- Ensuring alignment of approaches, policies, standards and procedures used to the greatest extent possible across the Quality groups responsible for Merck’s Small Molecule, Biologics and Vaccines product platforms
2
Responsibilities For Q&FS External Manufacturing Technologist Resume
- Maintenance of a robust change control system for the redesigned QMS to ensure compliance with latest regulatory requirements and to maintain alignment of MMD quality documents with local site guidance internally and externally
- Provide reviews, assistance and advice as required on processes related to departmental information
- Develop process documentation and innovative solutions to recommend/facilitate improvement efforts and assist
- Lead cross functional team through technical gap analysis, risk assessment and mitigation. Drive for process robustness, manufacturability and flawless ramp
- Collaborate with sending/receiving site for benchmarking, and sharing of lessons learned on pre mass production performance, process control, quality detection, and yield activities
- Manage assembly/test sites for manufacturing readiness
- Establish dual source supply chains for multiple processes and products across various business units
- Acts as the MSD Quality point of contact for technology transfers to the external partner and leads all quality aspects of the technology transfer
- Approves the release of vaccine and biologic products with the assurance that the goods were produced in conformance to all applicable policies/procedures of MSD and compliance with all governing regulations
3
Responsibilities For Assoc Dir External Manufacturing Resume
- Closely collaborates with appropriate business and operations areas to achieve MSD objectives
- Experience in a combination of: the management of drug manufacturing, filling and packaging either directly or through qualified CMOs; procurement; product development
- Experience in a Medical Device regulated environment
- Lean or Six Sigma (Green or Black Belt) Certification.3836170616
- Technical Writing Skills, Leadership and Supervisory Skills, Interpersonal Skills/Teambuilding Skills, Intermediate Computer Skills (Excel, Word, Powerpoint), Intermediate Communication Skills, Negotiation Skills, Time Management and Work Simplification, Can interpret technical drawings
- Extensive experience in and around a manufacturing environment, but also very comfortable in a corporate setting
- Food industry experience necessary to understand thoroughly the materials processes and supply chains of suppliers
4
Responsibilities For Director External Manufacturing Resume
- “Hands On” management style able to work across the enterprise at all levels
- Ten years of experience in pharmaceutical manufacturing industry (drug product or API) in areas such as operations, project management, quality, pharmaceutical technology or supply chain at a management level
- Computer Literate. Experience using Microsoft Office
- Identify potential threats to our ability to maintain unconstrained supply
- $75M - $150M in annual spend
- $120M - $250M in K-C revenue from managed products/suppliers
5
Responsibilities For Associate Director External Manufacturing Virtual Plant Manager Resume
- Support North America as well as global business units as assigned
- Fluent English, preferable fluent Russian
- Another language knowledge would be an asset
- Work independently with all levels of the organization is required
- Expert knowledge of cGMPs, Quality System expectations and associated Quality Manual Documentation at the Policy, Standard and Procedure levels
- Work effectively in team QMS workshops, brainstorming and Kaizen events, and work with employees across multiple site and product platform boundaries
- “see around the corner” of potential threats to our ability to maintain unconstrained supply
6
Responsibilities For Senior Manager, External Manufacturing Resume
- Fluency in English (both verbal and oral)
- Capable to manage multiple projects and activities on a regular basis
- Knowledge of artwork management systems
- Segment/Business Unit Finance Leadership
- Segment/Business Supply Chain Leadership
7
Responsibilities For External Manufacturing Sourcing Specialist Resume
- Global/Regional Procurement Category Leaders
- CEO’s and Senior leaders for suppliers
- External alliance organizations and associations
- Cost Improvement (CIPs)
- 15-30 global suppliers
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