Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
PETNET is expanding its team of Scientists, preparing to support a growing number of projects and new collaborations in PET drug manufacturing. A qualified candidate will lead method validation studies for any HPLC, GC, Radio-TLC or other non-microbiological quality control tests. The candidate should be an effective user of HPLC, GC or Radio TLC and have the ability to become a user in the other disciplines. The candidate should be able to become an expert in one of these pieces of equipment and SOPs within the first year of employment. The candidate would report to the PETNET Process Engineering Manager.
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- The candidate would lead the development of new analytical methods and validation of the analytical method.
- The candidate will transfer analytical methods from PETNET collaborators and assist in the method transfer process while transferring analytical methods from PETNET corporate to the PETNET manufacturing facilities
- The candidate would perform analysis of samples to support cleaning validation, process validations, and other development projects required within the development group.
- The candidate would perform or coordinate maintenance on analytical equipment in the development group.
- The candidate will assist in the evaluation of new analytical equipment for production facilities as well as develop or evaluate current IQ/OQ/PQ documentation for analytical equipment.
Required Knowledge/Skills, Education, and Experience
- A minimum of a Bachelors degree in Chemistry or a closely related field is required.
- 2-5 years in a GMP related industry is required.
- The candidate must understand method validation requirements in ICH guidelines and USP/NF.
- Must be able to qualify to handle radioactive materials.
- Ability to travel 0-5% of time
Preferred Knowledge/Skills, Education, and Experience
In this section, please outline exactly what knowledge/skills, education, and experiences are preferred but NOT required to be considered for this position.
- Excellent oral and written communication skills are necessary.
- Flexibility to adapt to changes; ability to take initiatives, prioritize, focus and deliver
- The individual in this role must be self-motivated, driven to exceed goals and is an advocate for change.
- The individual should be willing to engage in group activities and effectively communicate technical knowledge to others that may not have an analytical chemistry background.
- Experience with FDA and other regulatory agency audits is a plus.
- Experience handling radioactive material is a plus
- Experience in the PET or SPECT industry is a plus (21 CFR 212, USP 823).
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: PETNET Solutions, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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