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 make our company a community where we make a life, not just a living.
Who you are…
You are a data performance guru, technologically savvy, and easily turn in-depth technical data into discernable, actionable information. While juggling multiple projects and working with different teams, you stay focused with the end goal in mind.
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.
What you can expect to work on…
- 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 non-radioactive chemistry.
- Perform tracking & trending of process data, statistical analysis, & design of experiment studies using JMP.
- Generate reports & presentations of results of JMP tracking, trending, & analysis.
- Provide in-depth statistical expertise in the areas of; experiment, protocol, case report form design, data base structure, and analysis plan
What you need to succeed…
- Bachelor degree in science/engineering field or equivalent education/experience
- Chemistry, biochemistry, chemical, nuclear engineering or related field
- 6+ years’ experience in a chemical laboratory or related field
- 7+ years’ experience working with the following:
- Pharmaceutical environment
- Radioactive materials
- cGMP regulated environment
- Proficient in tracking process improvements and measuring business value realization
- 5+ years’ experience utilizing JMP to perform tracking & trending of process data, statistical analysis, and design of experiments
- 5+ years experience statistical computing expertise in R and breadth of general computational tools).
- 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.
- 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 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.
- Strong background in high-dimensional data analysis
- Expertise in predictive modeling, machine learning, and variety of classical statistical methods such as mixed-effects-models, nonlinear regression, etc.
Great to have…
- Master’s degree or PhD with strong foundation in statistics
- 8+ years’ experience in a chemical laboratory or related field
- 8+ years’ experience utilizing JMP to perform tracking & trending of process data, statistical analysis, and design of experiments
- Experience operating in a cGMP CDMO or Finished Drug environment.
- 10+ years’ experience working with the following:
- Pharmaceutical environment
- Radioactive materials
- cGMP regulated environment
Other Things to Note…..
- Full-time, On-site position.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
- Company’s 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 hours to operational commitments as needed.
Please provide a cover letter specifically describing your background and experience as it relates to this position.
