About Signatur Biosciences

We make precision diagnostics more accessible, starting with breast cancer prognosis. Current tests that guide the use of therapy are really slow and expensive because they need to be run in complex centralized facilities. Our tests are designed to be easily run by local hospital labs, reducing turnaround time from over three weeks to a few days and for half the price.

About the role

Skills:Biology

About the job

Signatur Biosciences was established with the mission of making cutting-edge diagnostic tools accessible to more patients around the world. The development of precision diagnostics has increasingly driven advances in life-saving personalized medicine, yet those innovations come with an ever-increasing price tag. Major players in molecular diagnostics have prioritized more and more complex and expensive equipment, rendering these advances inaccessible to many unless we do something about it.

Leveraging groundbreaking innovations in molecular design, we develop high-performance diagnostic tests that are specifically designed to run on equipment already found in biomedical labs around the world. We're worried about accessibility in precision diagnostics and are building a team of individuals who share our passion for solving this problem through close collaboration and a sense of urgency. We're building a different kind of company, where employees think like owners, act with authority, and collaborate closely with one another.

Signatur Biosciences is a spinout of Imperial College London, backed by YCombinator and based in New Heaven, Connecticut, and London, UK. We are seeking a highly motivated and driven RA/QA Manager to join our London team (remote work could be available). In this role, you’ll work closely with the CEO and CSO. You will be responsible for Regulatory Affairs and Quality Assurance activities. You will also be exposed to Clinical activities, and you will work closely with a team of interdisciplinary scientists to develop, validate, and commercialize our diagnostics assays. If you are a self-starter with a passion for novel diagnostics development, we'd love to speak with you!

Responsibilities:

Define and implement a Regulatory Strategy embedded within our Product Development Plan.
Interaction with Regulatory Bodies. Lead FDA/EU pre-submissions and submissions.
QMS implementation. Collaborate with and support the CSO and scientists.
Support Clinical activities, including the design and implementation of our clinical studies.

Qualifications:

Over 3 years of relevant industry experience, preferably within IVD/molecular diagnostics.
Led and navigated at least one IVD regulatory submission, demonstrating leadership and broad exposure. Hands-on experience with FDA/MDR submissions including the preparation of documentation and liaising with FDA and notified bodies/regulatory authorities.
Experience with QMS development and implementation activities followed by certification/ orchestrating the internal and external audit — owning the QMS.
Bachelor of Science degree in biology, molecular biology, synthetic biology, bioengineering, or similar
Excellent attention to detail, backed by exceptional note-taking and record-keeping skills.
Excellent communication skills.
Strong interest in interdisciplinary work, willingness to dive into new topics and understanding of medical requirements
Ability to effectively prioritize tasks in a dynamic and fast-paced environment

Nice-to-haves (but not required):

Speak more than one language.

Compensation and benefits at Signatur Biosciences include:

Base Salary + equity (compensation will be based on experience level with requested qualifications).
Generous paid time off policy that includes: 3 weeks, approximately 1 additional week during year-end holidays.
Private medical insurance could be offered
Employee Pension Scheme

As we continue to grow, our benefits package will evolve. The benefits outlined above are accurate as of the job posting date, but may differ at time of hire.

Signatur Biosciences is an equal-opportunity employer promoting diversity and inclusion in the workspace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.

Legal authorization to work in the UK is required. In compliance with UK law, all persons hired will be required to verify identity and eligibility to work in the UK and to complete the required employment eligibility verification form upon hire.

Technology

Our PCRchitectur platform is a technology that expands PCR testing to a whole new range of conditions beyond just infectious disease to include everything from treatment selection, chronic conditions, and disease monitoring.

We have re-engineered the molecular architecture of the polymerase chain reaction, empowering it to process the information from multiple biomarkers simultaneously. Rather than rely on laborious, repetitive protocols or expensive, specialized equipment, our innovative approach combines the power of gene expression profiling diagnosis with the ease and familiarity of a single PCR reaction.

Interview Process

Thank you for taking the time to learn more about Signatur Biosciences’ interview process.

Our interview process is designed to find profiles that are driven by our mission and can embrace working in a startup. Below is what to expect in our interview process. If you have questions, email us at celestin@signatur.bio

Phone Screen

This stage is a more informal call to learn more about the role and evaluate whether it’s a good fit for you. The conversation will cover some light discussion about your past projects. Mostly, we want to know more about your previous jobs and projects that you have been involved with.

Interview Process

The interview process is a deeper dive into your RA/QA expertise, thinking, and overall fit. For the “fit” portion, we are again looking for ownership and autonomy, but we also dig deeper into communication. This is evaluated throughout the process — in how you communicate your approach, solutions, and overall thinking.

The first interview with the CEO will be in person (in London). The second interview will be a call with the CSO (US-based). Each interview is ~1 hour long, with 15 minutes for Q&A.

Technical Check

This is a short interview with one of our partners/advisors to dive deep into your RA/QA expertise.

After the first interview, we sometimes short-circuit the process with a “no-hire”. Lastly, all candidates are invited to talk to our team members to better understand what it is like to work at Signatur Biosciences.

Timing

The typical interview process takes two weeks from start to finish. We will be moving quickly and look to accommodate candidates who might have a short timeline or competing offers. The more information you can share about your situation and where you are in the process, the more we can either attempt to expedite/match, or save you time if we cannot.

Signatur Biosciences remote jobs

RA/QA Manager