How will you make an impact?
When you join us at Thermo Fisher Scientific, youâll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
What will you do?
This project management role will support new product transfer into Carlsbad manufacturing. This role is responsible for product and manufacturing process development and transfer of new products using project management best practices. Representing manufacturing as the core team member on new product core teams, this individual will ensure all stakeholders within the department and within the project team are properly represented and that all product infrastructure and processes are defined, documented, verified, and managed while reducing manufacturing and operations risk at each phase of the transfer process.
- Represent Manufacturing and Operations on new product introduction core teams.
- Oversee the activities of all operations aspects involved in new product development to ensure a robust transfer from R&D to Manufacturing.
- Partner with R&D, Technical Operations (Manufacturing Sciences and Engineering), and Manufacturing work centers to deliver highly reproducible products and processes.
- Develop and maintain detailed plans and schedules for all tasks owned by Manufacturing/Operations.
- Perform manufacturing process design reviews and risk assessments.
- Generation and maintenance of the Manufacturability Index Scorecard both as a separate deliverable and as part of the Operations Report.
- Prepare reports and conduct reviews for Manufacturing/Operations readiness.
- Prepare written work instructions and manufacturing product documentation.
- Implement developmental outputs into product infrastructure, manufacturing process, documentation and procedures.
- Direct extended team activities.
- Effective communication of progress and challenges to all project stakeholders including, but not limited to, the project core team, functional department managers/supervisors, and extended team members.
- Manage multiple projects using project management best practices.
- Manage communication and deliverables of cross-site/external site projects
- May informally direct/supervise one or more junior level development scientists as assigned.
- Other duties as assigned.
How will you get here?
Education/Experience
Minimum Education/Experience Requirements:
- Bachelor’s degree (B. A., B.S., etc.) from four-year college or university and 8+ years post undergraduate experience in developing reagents for regulated/non-regulated markets, or 8+ years relevant experience in a biotechnology manufacturing environment, producing/developing products for the biotech/pharma/molecular diagnostic markets.
- M.S and 5+ years post undergraduate experience in developing reagents for regulated markets, or 5+ years post undergraduate experience in a biotechnology manufacturing environment developing products for regulated/non-regulated market.
- Ph.D. and 2+ years of postdoctoral experience developing reagents for regulated/non-regulated markets.
- Education and experience in Chemistry, Biochemistry, Molecular Biology, Biology, and assay development and/or light industrial process applications is required.
- Verbal and written fluency in English
Preferable Skills and Attributes:
- Understanding of ISO 9001 :2008 and ISO13485 requirements preferred
- Demonstrated documentation and communication skills,
- Familiar Design Excellence tools and principles: Six Sigma, DFSS, and DOE.
- Familiar with statistical analysis tools such as JMP and Minitab.
- Proficient use of MSOffice, MS Project, and Visio.
- Proficient use of Manufacturing/Operations systems. e.g. ERP systems
- Strong project management skills and knowledge.
- Ability to solve multilevel problems quickly and easily.
- Effective interdepartmental interactions.
- Personable, perpetuating a can-do positive attitude
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionâenabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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