MS&T Specialist

Niowave•Lansing, MI

About The Position

MS&T 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 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.

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 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
6+ years’ experience in a chemical laboratory or related field
7+ years’ experience working with the following: Pharmaceutical environment Radioactive materials cGMP regulated environment

Nice To Haves

Master’s degree in science/engineering field or equivalent education/experience preferred
Experience operating in a cGMP CDMO or Finished Drug environment preferred

Responsibilities

supporting manufacturing and technical transfer activities to support manufacturing readiness
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.