Manufacturing Science Technology Tech Transfer Lead
Manufacturing Science Technology Tech Transfer Lead
Posted on :
19-04-2025
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1 Vacancy
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Job Description
The MS&T Tech Transfer Lead position plays a key role in leading technology transfer activities of radioisotope production processes. This role acts as a leader in coordinating tech transfer efforts between Niowave & external groups. The MS&T Tech Transfer Lead is both highly organized and extremely communicative and is excited to represent Niowaves technological achievements to external groups. This role finds coordinating project resources & organizing effective scientific/engineering communication to be a desirable pastime. Words that describe the MS&T Tech Transfer Lead are proactive communicative persistent & thorough.
Essential Functions
- Responsible for the technology transfer of processes & analytical techniques for both internally and externally developed processes.
- Responsible for successful implementation and of tech transferred activities up through validation of transferred processes at external facilities.
- Serves as the liaison between Niowave & external parties including regular onsite representation at both Niowaves site and the external parties site.
- Coordinates participates and lead in tech transfer meetings to ensure successful delivery of project variables.
- Communicates performance progress challenges and achievements to stakeholders at all levels including senior management.
- Identify risks associated with technology transfer and develop proactive mitigation strategies.
- Controls data and material exchange between sending & receiving site.
- Trains staff in best practices to operate transferred processes.
- Works closely with external site to ensure proper batch documentation & provide technical & strategic oversight for med device manufacturing.
- Collaborates with crossfunctionl teams including MS&T operations engineering quality and regulatory to ensure effective technology transfer.
- Operates at a consistent and exemplary level of efficiency producing high quality and accurate results.
- 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.
- Ensures effective and ontime documentation is competed for both R&D and quality operations
- Educates project teams & production teams as to their role with projects & project initiation.
Competencies
- Problemsolving skills; excellent interpersonal written and oral communication skills; Organizational and project management skills for self and teams.
- 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 their own communication and learning styles can assess others styles and is able to find the right path to connect the two.
- Strong knowledge of cGMP and Regulatory expectations for Pharmaceutical products.
- Capable of influencing without authority at all levels of the organization and managing partner relationships effectively with various stakeholders
Minimum Education and Experience
- Bachelor degree in science/engineering field or equivalent education/experience
- Chemistry biochemistry chemical engineering or related field
- 4 years of biopharmaceutical process development and/or manufacturing experience
- 4 years experience working with the following:
- Radioactive material
- cGMP regulated work
- 2 years of Project management experience
Preferred Education and Experience
- Masters degree in a STEM discipline
- 6 years of biopharmaceutical process development and/or manufacturing experience
- Proficient in tracking process improvements and measuring business value realization
- Strong crossfunctional business acumen with a comprehensive understanding of endtoend supply chain processes
- 6 years experience with regulatory requirements and industry guidelines specific for the pharmaceutical industry (e.g. FDA GMP ICH etc.
- 4Project 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 a staff member to successfully perform the essential functions of this job.
- Use hands to finger handle or feel objects tools or controls
- Reach with hands and arms
- Climb stairs
- Walk throughout all locations of the company
- Talk and hear
- Wear safety glasses goggles gloves lab coat and/or Tyvek suit
- Occasionally lift or move office products and supplies up to 25 pounds
- Stand and sit for prolonged periods
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
- This is a hybrid position
- Travel is required for this position and includes up to two weeks per month travel for inperson work at both Niowave Lansing area sites and external companies site.
Employment Type
Full Time
Key Skills
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