MS&T Specialist

Niowave Inc. • Lansing, MI

6d • Hybrid

About The Position

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.

Requirements

• 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 radioactive materials
• 2+ years’ experience working in a 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

Nice To Haves

• 6+ years’ experience in a chemical laboratory or related field (for MS&T III)
• 7+ years’ experience working with pharmaceutical environment (for MS&T III)
• 7+ years’ experience working with radioactive materials (for MS&T III)
• 7+ years’ experience working in a cGMP regulated environment (for MS&T III)
• Master’s degree in science/engineering field or equivalent education/experience preferred
• Experience operating in a cGMP CDMO or Finished Drug environment preferred

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level