At a Glance
- Tasks: Lead the development of molecular diagnostic assays and manage FDA submissions.
- Company: Innovative nanotechnology company in Cambridge, MA, with a focus on healthcare solutions.
- Benefits: Competitive salary, opportunities for growth, and a chance to work on groundbreaking technologies.
- Other info: Dynamic work environment with a strong emphasis on innovation and collaboration.
- Why this job: Join a pioneering team making a real impact in healthcare through advanced technology.
- Qualifications: PhD in relevant field and extensive experience in IVD assay development required.
The predicted salary is between 60000 - 80000 £ per year.
Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE- the first X-PRIZE ever awarded for healthcare.
DUTIES
- Lead molecular diagnostic assay development in a hands‑on manner through successful FDA submission
- Manage and contribute to regulatory documents
- Project management; personnel management skills
- Design assay performance specifications
- Ensure assay development process meets milestones and timelines
- Troubleshoot and solve technical issues
- Maintain compliant laboratory documents and procedures
- Pro-actively improve efficiency, quality and effectiveness of R&D efforts
QUALIFICATIONS
- PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
- Minimum of 7 years of relevant industry experience and IVD assay development
- In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques
- Demonstrated technical, managerial and leadership expertise in assay development
- Strong understanding of FDA and global regulatory requirements
- Prefer commercial assay experience
- Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
- Prefer experience working in BSL-2 laboratory facilities
- Strong work ethic and ability to generate high quality work under tight deadlines
- Flexibility in work schedule
- Self-motivated, independent and a driving force of efficient execution
- Strong organizational and project management skills
- Excellent oral and written communication skills
Senior Scientist: IVD Assay Lead for FDA Submissions in Cambridge employer: Energy Jobline ZR
Nanobiosym is an exceptional employer, offering a dynamic work environment in the heart of Cambridge, MA, where innovation meets purpose. Employees benefit from a culture that fosters collaboration and creativity, alongside opportunities for professional growth in cutting-edge nanotechnology and biomedicine. With a commitment to impactful work and a history of recognition, including the prestigious X-PRIZE, Nanobiosym provides a unique platform for scientists to contribute to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Scientist: IVD Assay Lead for FDA Submissions in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who might know someone at Nanobiosym. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s projects and values. Show us you’re not just another candidate; demonstrate your passion for nanotechnology and how your experience aligns with their mission.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email. It shows your enthusiasm and keeps you fresh in their minds.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to connect directly with us.
We think you need these skills to ace Senior Scientist: IVD Assay Lead for FDA Submissions in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in IVD assay development and regulatory submissions. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about nanotechnology and how your background makes you the perfect fit for our team. Let us know what excites you about the role and Nanobiosym!
Showcase Your Technical Skills:Don’t forget to highlight your hands-on experience with techniques like qPCR and sequencing. We’re looking for someone who can lead assay development, so make sure we see your technical prowess right from the start!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss any important details. We can’t wait to hear from you!
How to prepare for a job interview at Energy Jobline ZR
✨Know Your Stuff
Make sure you brush up on your knowledge of nucleic acids biochemistry and molecular biology techniques. Be ready to discuss your hands-on experience with qPCR and sequencing, as well as any relevant projects you've led. This will show that you're not just familiar with the theory but can apply it practically.
✨Understand Regulatory Requirements
Familiarise yourself with FDA and global regulatory requirements related to IVD assay development. Being able to speak confidently about compliance and quality systems like GLP and ISO will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've managed teams and projects in the past. Highlight your ability to troubleshoot technical issues and improve R&D efficiency. This will help convey your managerial capabilities and leadership style, which are crucial for this position.
✨Communicate Clearly
Practice articulating your thoughts clearly and concisely. Since excellent oral and written communication skills are essential, consider preparing a brief presentation on a past project or achievement. This will not only showcase your communication skills but also your ability to engage with the interviewers.
