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Become A Research And Development Project Leader

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Working As A Research And Development Project Leader

  • Making Decisions and Solving Problems
  • Getting Information
  • Identifying Objects, Actions, and Events
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Deal with People

  • $76,502

    Average Salary

What Does A Research And Development Project Leader Do At Thermo Fisher Scientific

* Clinical Trials; preparation, testing, collecting isolates, tallying data.
* Manage Validation Studies, M23 Studies.
* Custom Panel Production; preparing custom panels for customers, broth's/media
* Prepare microbiology media; RPMI, MHB/LHB,VFM,MHF, Mueller Hinton Broth autoclave/preparation of equipment/glassware.
* Shipment preparation; Media/Broth's, frozen/dried panels, infectious substances, lab supplies
* Assists QA/RA with appropriate documentation and testing: panels/broth's/media, MIC trays, daily isolate QC transfer
* Frozen stock isolate maintenance, manage in house study supplies
* Performa drug isolate testing.
* Organize trial data for internal and external audits
* Prepare abstracts and posters for presentations at National meetings.
* Customer inquiry/complaint testing; Sensititre panels (dried and frozen).
* Provides support to technical services either for investigational work or customer assistance.
* Development of and adherence to Standard Operating Procedures.
* Drug development for commercial Antimicrobial susceptibility testing products.
* Consultation support for product customization and formulations
* Support Marketing projects for Microbiology Product Line, by providing technical information (technical product Inserts, sell sheets, technical information tool).
* Establish and maintain business relationships with new and existing customers

What Does A Research And Development Project Leader Do At Lilly

* This team role is responsible for conducting, leading and overseeing project management activities and strategy for Global Food Animal R&D projects with a focus on CMC (Chemistry ,Manufacturing & Control) including small molecules, biomedicine and some vaccines.
* The individual in this role interfaces with global FA R&D staff and works closely with team members in Regulatory, Manufacturing, Quality, Research & Development, Finance, New Product Planning, Innovation Strategy and Marketing to ensure that robust project plans are designed/ developed and risks are proactively identified and monitored to provide our customers with timely high quality products.
* Scope
* Independently manages project management activities (with a focus on CMC activities with small molecules and biomedicine) for either a) a substantive development program (e.g., a high cost and/or a high complexity development plan; or parallel development of multiple and/or novel indications) with substantive business impact (e.g., registration program for a high priority PLE), or b) a subset of an early phase therapeutic area portfolio.
* Provides input on strategy for implementing the development plan (specifically the CMC portion), developing realistic project milestones and deliverables, and linking development plan to the intended label.
* Leads a team to develop and maintain appropriate development scope documentation; update development plan at least annually, or after major modifications in scope, resources or timeline and secure team/leadership alignment around the new development plan
* Utilizes external inputs and ideas, leveraging business process knowledge to drive transformation within the function and cross-functionally
* Timeline
* Develops and maintains up-to-date development plan timelines (using Microsoft Project) and process maps (if appropriate)
* Identifies, communicates and manages the critical path and leading indicators of the team’s progress to major development milestones
* Monitors and reports performance to plan and works with Director to drive team action when plan is not being achieved
* Manages upcoming team-related activities, key milestones, and decisions as well as to proactively identify updates to development schedule; initiate development schedule updates on a regular basis and revise schedule as appropriate.
* Drives data completeness and accuracy within business systems by team, functions, and geographies
* Budget
* Partners with Financial, functions and geographies, to manage the overall development budget for the team
* Consults with development team to understand variances to the plan/forecast and reasons for the discrepancies.
* Drives re-forecasts
* Provides the team and leadership an understanding of the cost of development options
* Risk
* Leads assessment of development risks, mitigation/contingency planning and assignment of ownership.
* Independently identifies and triggers when those plans should be implemented
* Proactively identifies and communicates to the team the risks that may affect the development critical path and impact portfolio milestones, and proactively takes action to mitigate or avoid those risks.
* Quality
* Applies “quality mindset” to completion of all study and project tasks.
* Liaises with Director to escalate of issues.
* Communication & Team Management
* Influences and works with quality mindset across the development team by documenting key decisions, actions and key modifications in development scope, resources and timeline; ensuring accurate collection and communication of development metrics
* Ensures coordination of development meeting logistics and provision of timely meeting agendas and meeting minutes
* Submission Planning and Execution
* Works with the development team to create the overall development submission plan and timeline including critical path management, track progress against timeline, and drive resolution of issues to meet submission milestones
* Capacity Planning/Management
* Through conducting risk assessment and creating contingency plans for development projects, will immediately understand the impact of any resource “roadblocks” that may affect timelines
* Assesses impact of clinical scope changes and provides recommendations to the team regarding the resource/budget implications of these changes
* Application/Improvement of Processes (Shared Learning)
* Generates ideas for new processes and drives process improvement within Food Animal to enhance function of team.
* Ensures the utilization and consistency of documented business processes
* Identifies and shares learning opportunities and process improvements with the team and function in order to streamline the effectiveness/efficiency of conducting development trials; identify methods to decrease development cycle times
* Liaises across Project Management R&D groups to identify, share, and incorporate best practices into future iterations of processes, tools, training, or guidance.
* Independently represents FA R&D on cross-functional teams (e.g., Six Sigma) and represents output from those teams to leadership.
* Solution-oriented, seeking input from people with first-hand knowledge of issues, along with gathering data on past projects, etc. to help resolve issues and determine best future options for the project
* Leads and participates in retrospective project/process review meetings (i.e. after action reviews) to identify issues and strengths and help capture and implement learning.
* Assure that shared learning is made available
* Req ID:
* BR

What Does A Research And Development Project Leader Do At J&J Family of Companies

* Serve as project manager of a multifunctional
* team to drive new product development activities from concept to launch.
* Develop and validate methods for reprocessing of
* assigned devices.
* Performs complex hands-on and simulated testing
* for design verification and test method developments.
* Reviews and edits all engineering documentation
* related to assigned projects, such as technical reports, work instructions and method
* and process validation.
* Leads basic engineering operations, and complex
* scientific evaluation on new products, technology concepts, and product
* development.
* Implements complex design concepts and ideas
* into working blueprints and drawings.
* Studies specifications, engineering blueprints,
* tool orders, and shop data and confers with engineering and shop personnel to
* resolve design problems related to material characteristics, dimensional
* tolerances, service requirements, manufacturing procedures, and cost.
* Applies complex algebraic and geometric formulas
* and advanced tool engineering data to develop product configurations.
* Inspects and oversees testing of prototypes,
* tools, and fixtures after fabrication to ensure that they meet specifications.
* Write verification and validation documentation
* and conduct required testing as needed
* Familiar with all aspects of medical device
* product development, including design, verification and validation, FDA
* submission, and design transfer into manufacturing.
* Perform reverse engineering to identify
* functional and performance requirements for reprocessed devices
* Oversee design and build of new components and
* assembly tooling
* Perform testing and inspection functions
* including forensics and root cause analysis
* Assist regulatory compliance efforts and
* verification and documentation related to engineering standards
* Author, revise, train, and provide support for
* production work instructions.
* Identify new processing needs and perform
* continuous improvement to support sustaining efforts
* Perform reverse engineering to identify
* functional and performance requirements for reprocessed devices
* Proficient in the investigation and management
* of CAPA’s, root cause analysis, complaints, and escalations.
* Lead and facilitate process improvement
* activities
* Role may include project and team management
* responsibilities
* Committed to building a positive culture
* Other responsibilities may be assigned & not
* all responsibilities listed may be assigned

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How To Become A Research And Development Project Leader

Industrial engineers must have a bachelor’s degree. Employers also value experience, so cooperative education engineering programs at universities are also valuable.

Education

Industrial engineers need a bachelor’s degree, typically in industrial engineering. However, many industrial engineers have degrees in mechanical engineering, electrical engineering, manufacturing engineering, industrial engineering technology, or general engineering. Students interested in studying industrial engineering should take high school courses in mathematics, such as algebra, trigonometry, and calculus; computer science; and sciences such as chemistry and physics.

Bachelor’s degree programs include lectures in classrooms and practice in laboratories. Courses include statistics, production systems planning, and manufacturing systems design, among others. Many colleges and universities offer cooperative education programs in which students gain practical experience while completing their education.

A few colleges and universities offer 5-year degree programs in industrial engineering that lead to a bachelor’s and master’s degree upon completion, and several more offer similar programs in mechanical engineering. A graduate degree allows an engineer to work as a professor at a college or university or to engage in research and development. Some 5-year or even 6-year cooperative education plans combine classroom study with practical work, permitting students to gain experience and to finance part of their education.

Programs in industrial engineering are accredited by ABET.

Important Qualities

Creativity. Industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal.

Critical-thinking skills. Industrial engineers create new systems to solve problems related to waste and inefficiency. Solving these problems requires logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to the problems.

Listening skills. These engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff. They must listen to customers and clients in order to fully grasp ideas and problems the first time.

Math skills. Industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work.

Problem-solving skills. In designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance.

Speaking skills. Industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available. Being able to explain concepts clearly and quickly is crucial to preventing costly mistakes and loss of time.

Writing skills. Industrial engineers must prepare documentation for other engineers or scientists, or for future reference. The documentation must be coherent and explain their thinking clearly so that the others can understand the information.

Licenses, Certifications, and Registrations

Licensure is not required for entry-level positions as an industrial engineer. A Professional Engineering (PE) license, which allows for higher levels of leadership and independence, can be acquired later in one’s career. Licensed engineers are called professional engineers (PEs). A PE can oversee the work of other engineers, sign off on projects, and provide services directly to the public. State licensure generally requires

  • A degree from an ABET-accredited engineering program
  • A passing score on the Fundamentals of Engineering (FE) exam
  • Relevant work experience, typically at least 4 years
  • A passing score on the Professional Engineering (PE) exam

The initial FE exam can be taken after one earns a bachelor’s degree. Engineers who pass this exam are commonly called engineers in training (EITs) or engineer interns (EIs). After meeting work experience requirements, EITs and EIs can take the second exam, called the Principles and Practice of Engineering.

Several states require engineers to take continuing education in order to keep their licenses. Most states recognize licenses from other states, as long as the other state’s licensing requirements meet or exceed their own licensing requirements.

Advancement

Beginning industrial engineers usually work under the supervision of experienced engineers. In large companies, new engineers also may receive formal training in classes or seminars. As beginning engineers gain knowledge and experience, they move on to more difficult projects with greater independence to develop designs, solve problems, and make decisions.

Eventually, industrial engineers may advance to become technical specialists, such as quality engineers or facility planners. In that role, they supervise a team of engineers and technicians. Obtaining a master’s degree facilitates such specialization and thus advancement.

Many industrial engineers move into management positions because the work they do is closely related to the work of managers. For more information, see the profile on architectural and engineering managers.

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Research And Development Project Leader jobs

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Research And Development Project Leader Demographics

Gender

  • Male

    68.0%
  • Female

    26.9%
  • Unknown

    5.1%

Ethnicity

  • White

    65.8%
  • Asian

    20.6%
  • Hispanic or Latino

    10.1%
  • Unknown

    2.4%
  • Black or African American

    1.2%
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Languages Spoken

  • Portuguese

    12.5%
  • Chinese

    12.5%
  • Finnish

    12.5%
  • German

    12.5%
  • French

    12.5%
  • Carrier

    12.5%
  • Spanish

    12.5%
  • Korean

    12.5%
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Research And Development Project Leader

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Research And Development Project Leader Education

Research And Development Project Leader

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Top Skills for A Research And Development Project Leader

GenesisRNewProductDevelopmentLabFDAProjectManagementRegulatoryComplianceTechnicalSupportDProjectClinicalTrialsQADOEPosterPilotPlantRunsCostReductionAPITestMethodsProductSpecificationsHighQualitySolidworksCommonDevelopmentProcess

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Top Research And Development Project Leader Skills

  1. Genesis R
  2. New Product Development
  3. Lab
You can check out examples of real life uses of top skills on resumes here:
  • Led new product development for surgical attachments.
  • Supervised two technicians and trained them on testing processes and procedures, computer programs, lab equipment, and troubleshooting.
  • Supported clinical trials, FDA submissions, and product launches.
  • Transitioned to Project Management Competency Center in 2/10 where acquired specialized skills in Agile Scrum Project Management being currently leveraged.
  • Provide technical support, formulation development, and scale-up consultation on projects.

Top Research And Development Project Leader Employers

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Research And Development Project Leader Videos

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