- Develop new product designs, processes, new product scale-up, design/product optimization, technology transfer, process/product verification and validation activities, production procedures and process/product specifications
- Be responsible and direct the technical development of immunoassay projects, ensuring project meets design requirements on budget and within schedule, while ensuring timely transmission of data to project teams
- Independently design, execute, and analyze moderate to complex experimental works, present conclusions, develop and execute in-laboratory test protocols, Identify and resolve technical and not-technical issues, and maintain well organized laboratory notebooks in compliance with relevant procedures. Align with regulatory guidelines and Beckman Coulter Standard Operating Procedures (SOPs)
- Use expertise to improve technical rigor of the Reagent/IA R&D while also providing technical leadership within department, including training other scientists
- Represent the Reagent R&D team on cross-functional teams to achieve project and business commitments
- Bachelor's degree in field with 9+ years experience or Master's degree in field with 7+ years experience or Doctorate degree in field with 4+ years experience
- Demonstrated experience developing immunoassays in a ISO9000/FDA regulated environment
- Candidates must have considerable knowledge of good laboratory practices, scientific methods, as well as working knowledge of statistical methods and design of experiments
- Ability to document work per ISO9000/FDA regulation; including materials, methods, and conclusions as well as demonstrated ability to independently design, execute, analyze and draw conclusions form scientific experiments
- Demonstrated ability to work well in a team setting and able to interact effectively at all levels and across different cultures
- Commercialized RUO or IVD assays
- Experience achieving regulatory clearance for IVD products
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Staff Development Scientist - Chaska, United States - Beckman Coulter Diagnostics
Description
Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Staff Development Scientist for Beckman Coulter is responsible for completing assignments requiring independent thought, judgement, and initiative. Candidate should be self-driven and require limited instruction for routine to complex work and on new assignments. Candidate should be able to assist in developing new techniques and procedures that lead to greater departmental efficiency and improve the technical rigor of the reagent R&D team. All work must also meet regulatory requirements and follow company policies and procedures. Candidate should have a willingness to work in an ISO9000/FDA regulated environment.
The position is part of the Reagent Development Department located in Chaska (Minneapolis), MN and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Reagent Development Team and report to the Manager of Development Science and will be responsible for development and commercialization of immunoassays for an automated system. If you thrive in a collaborative, fast-paced, problem-solving role, have confirmed experience in chemistry, biochemistry, immunochemistry, immunology, or cell biology and prior experience in the development and commercialization of immunoassay IVD or RUO products, and want to work to build a world-class immunoassay Reagent Development organization - read on.
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
If you've ever wondered what's within you, there's no better time to find out.