Head of Molecular Sciences
6 months ago
**About ANGLE**:
ANGLE is a world-leading liquid biopsy company commercialising a patent protected platform technology that can capture rare circulating tumour cells (CTCs) from blood, in a mínimally invasive way, for downstream analysis.
ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood. Parsortix technology comprises a microfluidic device that captures CTCs from blood based on their size and compressibility. CTCs are cancer cells that have detached from the primary tumour and entered the blood circulation, and they play a critical role in initiating metastasis. Once harvested, the CTCs can be comprehensively analysed to provide a wealth of information about the patients tumour, advancing cancer research and potentially personalized medicine. This technology has the potential to deliver profound improvements in clinical and health economic outcomes.
ANGLE has established a CTC harvest and analysis service from our UK-based Clinical Laboratory based in Guildford for customers worldwide. In alignment with company priorities, we plan to rapidly expand our services to include molecular profiling of CTCs and ctDNA using digital PCR and NGS to add to our image-based assays.
**Join our Team**:
Reporting to the Senior Director, Head of R&D, the Head of Molecular Sciences is responsible for managing the Molecular Biology groups and activities with the overarching goal of product development.
Further, the Head of Molecular Sciences must be able to work across the organisation and, specifically, with other Head of Department, Group Leaders and Directors to ensure success of projects and company goals.
At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.
We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.
**Principal Accountabilities**:
- Act as molecular biology expert within the organisation.
- Provide scientific expertise and advise senior management in all technical areas of the company (mainly molecular biology);
- Provide detailed, comprehensive plans and specifications for projects;
- Identify, document and manage dependencies and risks for projects;
- Manage Molecular Biology teams (including R&D and Tech Transfer);
- Manage projects in a matrix structure across molecular biology, cell biology, engineering, IT, regulatory/clinical and quality;
- Manage procedures and metrics to monitor and mitigate risk and to ensure product deadlines are met;
- Identify and drive countermeasures in instances when projects are overdue or exceeding budget;
- Responsible for achievement of QCD (Quality, Cost, Delivery) metrics for projects;
- Manage relationships with external organisations and collaborators as required;
- Communicate programme/project status and plans to senior management;
- Work within the New Product Development process and provide documentation and supporting evidence to ISO13485 and 21cfr820 standard for gate reviews;
- Develop products in line with ISO 15389:2022 and CAP/CLIA requirements for transfer to the clinical laboratory
- Represent the company to customers and at external scientific meetings as required;
- Foster highest standards of integrity and quality of data within the organisation;
- Write/review external scientific publications and Application Notes;
- As required, work with marketing and/or business development to understand and document customer/product requirements;
- Provide technical support as required to the TAC team to support commercial partnerships and customers.
- Undertake additional ad-hoc tasks as required
**Qualifications, Experience, Knowledge and Attributes**:
- PhD preferably in molecular biology, and cancer genetics, with postdoctoral experience, ideally in the in vitro diagnostics industry and specifically in diagnostic assay development/validation.
- Must have strong molecular biology experience, in the development and implementation of molecular assays (including NGS and digital PCR) in the clinical domain;
- An eye for detail and a commitment to high quality data;
- Experience in managing people working in multi-disciplinary project teams, preferably in a matrix-based organisation;
- Must have experience working in a regulated environment medical device or therapeutics;
- Ability to understand Clinical Standards;
- Experience with Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, IVD 98/79 EC, ISO14971, GMP, GLP and QSR, ISO 15189 and CAP/CLIA a definite plus;
- Experience and demonst
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