Production Specialist Shift Lead (Radioisotopes)

• Executes chemistry operations and production of medical radioisotope products (including raw material preparation line clearance and cleaning equipment/instrument setup etc.).
• Maintains compliance with cGMP practices; participating in quality training and event retrospectives.
• Implements production methods and product formulation to resolve problems and accomplish specific objectives.
• Operates at a consistent and exemplary level of efficiency producing high quality and accurate results.
• Participates in periodic reviews of component labor routing material requirements and manufacturing procedures.
• Participates in new product / process transfers and validations.
• Contributes to inventory management including cleaning supplies and personal protective equipment (PPE).
• Demonstrates accountability of self in following radiation and general safety procedures and promotes a culture of safety by helping others to do the same.
• Maintains records in a comprehensive reproducible and accurate manner.
• Cold chemistry preparation including making solutions columns compounds etc.
• Leads production shift operations with a small team Production Specialists
  • Responsible for safety and quality compliance
  • Drives performance excellence for individuals and the team as a whole
  • Ensures the onboarding training and career development of staff members
• Executes on (Key Performance Indicators) KPIs communicates key program updates and drives improvements in quality safety and productivity to ensure KPIs are met.
  • Monitor production team against given KPIs and other success criteria
  • Process workflows production operations schedules staffing levels and equipment utilization.
• Within the department and across the organization fosters a culture of respect safety quality and continuous improvement aligning with the mission vision and values of the organization.
  • Coordinates with key stakeholders in the organization to ensure production objectives are met and staff are properly developed and trained.
  • Collaborates with other leads and leadership for improvements and tactical planning

• Bachelor degree in science/engineering field or equivalent education/experience
  • Chemistry biochemistry chemical engineering or related field
• 4 years experience working in a chemical laboratory or related field and working with the following:
  • Radioactive material
  • Ongoing/routine production environment
  • cGMP regulated work
• Can serve as shift lead on any shift
• Analytical and problem-solving skills; excellent interpersonal written and oral communication skills; Organizational and project management skills for self and teams.
• Proficient in Microsoft applications.
• 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 desire capability and regularly engages in mentoring others in the how & why of standard practices related to operations and those becoming mentors at the RPS II III and IV levels.

• Masters 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
• 4 years experience operating in a cGMP CDMO or Finished Drug environment.
• 6 years experience working with the following:
  • Pharmaceutical environment
  • Radioactive materials
  • cGMP regulated environment

• Full-time position.
• The companys standard operating hours are Monday thru Friday 6a 6p with production-related activities requiring 24/7/365 shifts.
• This position is a part of shift work including nights weekends and holidays.
• Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.

Required Experience:

Unclear Seniority