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 isresponsible 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 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
- Masters 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
- Niowaves 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.
| Required Experience:
IC
MS&T SpecialistWho we areWe 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 corn...
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 isresponsible 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 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
- Masters 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
- Niowaves 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.
| Required Experience:
IC
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