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 non-radioactive chemistry.
- Ensure effective and on-time 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 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.
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 cross-functional business acumen with a comprehensive understanding of end-to-end 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
- Master’s 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
- Full-time position.
- Company’s 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.
Please provide a cover letter specifically describing the nature of your technical expertise.
