Manufacturing Science Technology Project Lead
Manufacturing Science Technology Project Lead
Posted on :
09-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
09-04-2025
Job Description
Manufacturing Science & Technology Project Lead
Summary/Objective
The MS&T Project Lead position plays a key role in optimizing existing radioisotope production processes and expanding current processes into new frontiers. This role serves as a leader shepherding projects from ideation through R&D and ultimately through validation.
Staff members in roles in MS&T are technically oriented love research & development and find continuous improvement to be invigorating.
The MS&T Project Lead finds coordinating project resources organizing tactical scientific efforts & optimizing system performances to be a desirable pastime. You inspire others to celebrate the journey as a learning experience and embrace the desire to constantly improve themselves as well as processes.
Words that describe the MS&T Project Lead are curious persistent organized engaging and encouraging.
Essential Functions
- Develop & Implement process & system changes to improve production scale reliability & quality.
- Execute chemistry and medical radioisotope testing operations. (including raw material preparations equipment setup and cleaning equipment/instrument setup etc.
- Perform production process tracking trending & analysis.Executes on analytical & process improvements for radioisotope production operations.
- Support the investigations & action items for NCMRs & CAPAs that occur during production operations.
- Operates at a consistent and exemplary level of efficiency producing high quality and accurate results.
- Participates in new product / process transfers and validations.
- Maintains compliance with cGMP practices; participating in quality training and event retrospectives.
- 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.
- Commission new equipment with radioactive and nonradioactive chemistry.
- Ensure effective and ontime documentation is competed for both R&D and quality operations
- Lead own & track projects falling under MS&T purview.
- Prepare & present project pitches statuses & updates to the Project Steering Committee
- Interface across departments to coordinate efforts & push projects to completion
- Provide technical support & communication to partners & customers.
- Educate project teams & production teams as to their role with projects & project initiation.
Competencies
- Embraces & 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.
- Understands and applies the basic principles of project management according to the PMBOK.
- Demonstrates accountability of self in following radiation and general safety procedures and promotes a culture of safety by helping others to do the same.
- Displays continuous improvement mindsets and behaviors to drive operational excellence.
- Strong analytical and problemsolving 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.
Minimum Education & Experience for MS&T Project Lead I
- Bachelor degree in science/engineering field or equivalent education/experience
- Chemistry biochemistry chemical nuclear engineering or related field
- 4 years experience in a chemical laboratory or related field
- 4 years experience working with the following:
- Pharmaceutical environment
- Radioactive materials
- cGMP regulated environment
- 2 years of being part of project management driven work processes
- Exposure to and ability to apply project management philosophies for self and teams
Minimum Education and Experience for MS&T Project Lead II
- Bachelor 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
- 6 years experience working with the following:
- Pharmaceutical environment
- Radioactive materials
- cGMP regulated environment
- Proficient in tracking process improvements and measuring business value realization
- Strong crossfunctional business acumen with a comprehensive understanding of endtoend supply chain processes
- 4 years experience in applying project management philosophies for self and teams
Preferred Education and Experience for MS&T Project Lead II
- Masters degree in science/engineering field or equivalent education/experience
- Chemistry biochemistry chemical nuclear engineering or related field
- 6 years of biopharmaceutical process development and/or manufacturing experience
- 6 years of experience with regulatory requirements and industry guidelines specific for the pharmaceutical industry (e.g. FDA GMP ICH etc.
- 6 years of Project management experience
- Project management certification (e.g. PMP or FPX)
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Stand; walk; sit; stand and sit for prolonged periods
- Use hands to finger handle or feel objects tools or controls
- Vision abilities including near vision/acuity and visual color discrimination
- Talk and hear
- Reach with hands and arms
- Climb stairs
- Wear safety glasses goggles gloves and Tyvek suit
- Handle chemicals solutions and/or radioactive materials
- Ability to lift or move products and supplies up to 25 pounds.
Position Type/Expected Hours of Work/Travel
- Fulltime position.
- Companys standard operating hours are Monday thru Friday 6a 6p with production related activities requiring 24/7/365 shifts. This position will have regular working hours during M F with an expectation of adjusting work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Required Experience:
Senior IC
Employment Type
Contract
Key Skills
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