Manufacturing Science Technology Specialist
Manufacturing Science Technology Specialist
Posted on :
09-04-2025
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1 Vacancy
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Job Description
Manufacturing Science & Technology Specialist
Summary/Objective
The MS&T Specialist position plays a key role in the production of various medical radioisotopes using extraction methods developed at Niowave. The products will be shipped around the world for use in cancer therapies. 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.
The MS&T Specialist finds performing new experiments & optimizing system performances to be a desirable pastime. The MS&T Specialist is technically oriented loves research & development and finds continuous improvement to be invigorating. Words that describe the MS&T Specialist are curious persistent thorough and someone who collaborates well in the optimization of processes and documentation creating synergy for MS&T team members and RPS team members for chosen outcomes.
Essential Functions
- Works crossfunctionally with other departments to effectively transfer and maintain processes in the facility.
- Develop & implement process & system changes to improve production scale reliability & quality
- Develops and executes design transfer plans for new products and maintain process documentation for new and existing programs.
- Prepares and executes procedures protocols reports and plans for assigned processes in a radiological environment.
- Creates and documents recommended maintenance strategies for relevant systems in collaboration with key stakeholders applying riskbased decisionmaking practices and balancing performance cost and risk.
- Reviews and investigates 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.
- Executes the creation of risk assessments gap analyses deviations change controls and CAPAs including determination of product or process impact rootcause analysis and corrective action and preventative action identification.
- Executes chemistry and medical radioisotope testing operations. (including raw material preparations equipment setup and cleaning equipment/instrument setup etc.
- Performs production process tracking trending & analysis.
- Executes on analytical & process improvements for radioisotope production operations.
- Supports the investigations & action items for NCMRs & CAPAs that occur during production operations.
- Operates at a consistent and exemplary level of efficiency producing high quality and accurate results.
- Maintains compliance with cGMP practices; participating in quality training and event retrospectives.
- Maintains records in a comprehensive reproducible and accurate manner.
- Conducts cold chemistry preparations including making solutions columns compounds etc.
- Commissions new equipment with radioactive and nonradioactive chemistry.
Competencies
- Demonstrates accountability of self in following radiation and general safety procedures and promotes a culture of safety by helping others to do the same.
- Displays continuous improvement mindsets and behaviors to drive operational excellence.
- Strong analytical and problemsolving 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.
- Embraces & Models the Niowave 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 connect the two.
Minimum Education and Experience for MS&T Levels II
- Bachelor 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 material
- cGMP regulated environment
Minimum Education and Experience for MS&T Levels III/IV
- Bachelor degree in science/engineering field or equivalent education/experience
- Chemistry biochemistry chemical nuclear engineering or related field
- 4 years experience in a chemical laboratory or related field
- 3 to 5 years experience working with the following:
- Radioactive material
- cGMP regulated environment
Preferred Education and Experience for MS&T Levels III/IV
- Masters degree in science/engineering field or equivalent education/experience
- Chemistry biochemistry chemical nuclear engineering or related field
- 4 years experience in a chemical laboratory or related field
- Experience operating in a cGMP CDMO or Finished Drug environment.
- 5 years experience working with the following:
- Pharmaceutical environment
- Radioactive materials
- cGMP regulated environment
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Stand; walk; sit; stand and sit for prolonged periods
- Use hands to finger handle or feel objects tools or controls
- Vision abilities including near vision/acuity and visual color discrimination
- Talk and hear
- Reach with hands and arms
- Climb stairs
- Wear safety glasses goggles gloves and Tyvek suit
- Handle chemicals solutions and/or radioactive materials
- Ability to lift or move products and supplies up to 25 pounds
Position Type/Expected Hours of Work/Travel
- Fulltime position.
- Companys standard operating hours are Monday thru Friday 6a 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M F with an expectation of adjusting work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Please provide a cover letter specifically describing the nature of your technical expertise.
Required Experience:
Unclear Seniority
Employment Type
Full Time
Key Skills
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