MS&T Specialist

Niowave, Inc.; Lansing (MI); On-site; USD 65,000 - 85,000; Full time

Job summary

Niowave, Inc. is seeking a Manufacturing Science & Technology Specialist in Lansing, MI. This full-time position involves developing protocols and improving medical radioisotope production processes. Ideal candidates will have a Bachelor’s degree in a science or engineering field and at least 3 years of relevant experience.

The role requires strong analytical abilities, organizational skills, and effective communication. Responsibilities also include supporting the manufacturing and technical transfer activities, ensuring compliance with regulatory guidelines.

Qualifications

• 3+ years’ experience in a chemical laboratory or related field.
• Experience with radioactive materials and cGMP regulated environments.
• Strong analytical and problem-solving skills required.

Responsibilities

• Develop and implement process changes to improve production.
• Prepare and execute maintenance procedures and protocols.
• Support investigations for NCMRs and CAPAs during production.

Skills

Analytical skills

Problem-solving skills

Interpersonal communication

Organizational skills

Education

Bachelor’s degree in science/engineering

Tools

Laboratory equipment

Chemistry lab tools

Job description

Manufacturing Science & Technology Specialist

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 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 recommend 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.
• 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, knows how and when to make suggestions, and uses 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.