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MS&T Specialist

Niowave
  • Lansing, Michigan
    30+ days ago

    Job Description

    Manufacturing Science & Technology Specialist 
     
    Who we are…
    We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
     
    Who you are…
    You find performing new experiments & optimizing system performances to be a desirable pastime. You are technically oriented, love research & development, and find continuous improvement to be invigorating. Words that describe you are curious, persistent, thorough, and someone who collaborates well in the optimization of processes and documentation, creating synergy for MS&T and other team members for chosen outcomes.
     
    What you can expect to work on…
    The Manufacturing Science & Technology (MS&T) Specialist position plays a key role in the production of various medical radioisotopes using extraction methods developed at Niowave. The role is responsible for supporting manufacturing and technical transfer activities to support manufacturing readiness. This includes developing and executing operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations.
    • Work cross-functionally with other departments to effectively transfer and maintain processes in the facility
    • Develop & implement process & system changes to improve production scale, reliability, & quality
    • Prepare and execute procedures, protocols, reports, and plans for assigned processes in a radiological environment
    • Create and recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost and risk
    • Review and investigate system/equipment failure incidents, formulate, and record lessons learned, and continually improve and optimize system operation and maintenance strategies through implementation of corrective and preventive actions
    • Execute the creation of risk assessments, gap analyses, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action and preventative action identification
    • Execute chemistry and medical radioisotope testing operations. (including raw material preparations, equipment setup, and cleaning equipment/instrument setup, etc.)
    • Support the investigations & action items for NCMRs & CAPAs that occur during production operations
    • Conduct cold chemistry preparations including making solutions, columns, compounds, etc.
    What you need to succeed…
    • Bachelor’s degree in science/engineering field or equivalent education/experience
      • Chemistry, biochemistry, chemical, nuclear engineering or related field 
    • 3+ years’ experience in a chemical laboratory or related field
    • 2+ years’ experience working with the following:
      • Radioactive materials
      • cGMP regulated environment
    • Embraces and models the Niowave Core Values of Teamwork, Courage, Integrity, and Upright Zeal
    • Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state
    • Understands your own communication and learning styles, can assess others’ styles, and is able to find the right path to best connect with colleagues
    • Strong analytical and problem-solving skills
    • Excellent interpersonal, written, and oral communication skills
    • Highly developed organizational skills
    • Demonstrates capability and regularly engages in mentoring others in the how & why of standard work
    What you need to succeed – MS&T III
    • Above items and….
    • 6+ years’ experience in a chemical laboratory or related field
    • 7+ years’ experience working with the following:
      • Pharmaceutical environment
      • Radioactive materials
      • cGMP regulated environment
    • Master’s degree in science/engineering field or equivalent education/experience preferred
    • Experience operating in a cGMP CDMO or Finished Drug environment preferred
    Other things to know…
    • Full-time position
    • Niowave’s standard operating hours are Monday – Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shifts
    • This position will have regular working hours Monday – Friday with an expectation of adjusting work time outside of the standard operating hours as needed
    • Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
     
    Please provide a cover letter specifically describing the nature of your background and experience as it relates to this position.

    Numbers & Facts

    LocationLansing, Michigan
    Websitehttps://www.niowaveinc.com/index.php/careers-2/

    Skills

    • Analysis Skillsunmatched
    • Biochemistryunmatched
    • Biotech and Pharmaceuticalunmatched
    • Cancerunmatched
    • Change Controlunmatched
    • Chemical Engineeringunmatched
    • Chemistryunmatched
    • Cleaning Equipmentunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Documentationunmatched
    • Gap Analysisunmatched
    • Interpersonal Skillsunmatched
    • Manufacturingunmatched
    • Medical Testsunmatched
    • Mentoringunmatched
    • Nuclear Engineeringunmatched
    • Operational Strategyunmatched
    • Operations Processesunmatched
    • Organizational Development/Managementunmatched
    • Organizational Skillsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Developmentunmatched
    • Process Improvementunmatched
    • Production Systemsunmatched
    • Research & Development (R&D)unmatched
    • Riskunmatched
    • Risk Analysisunmatched
    • Root Cause Analysisunmatched
    • System Operationsunmatched
    • Systems Maintenanceunmatched
    • Team Playerunmatched
    • Writing Skillsunmatched

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