Clinical Assay Development Manager – ANGLE North America Inc. or ANGLE Europe Ltd. 

Guildford, UK

Come and join our dynamic team of highly skilled, passionate, creative professionals who together are advancing  rare cell diagnostics and making precision medicine a reality.

ANGLE is a world leading liquid biopsy company with offices in Guildford (UK), Toronto (Canada) and  Pennsylvania (US). ANGLE’s proven patent protected liquid biopsy platforms include the Parsortix® system, for  the enrichment of rare cells, including circulating tumor cells (CTCs), from blood, and the HyZip system, for the  highly sensitive, multiplexed and cost-effective analysis of RNA, DNA and/or proteins. Together the technologies  provide sample to answer molecular analysis of CTCs from a simple blood draw.

ANGLE’s liquid biopsy technologies have the potential to help clinicians select the most appropriate drugs and  therapies for an individual patient. As such, our technologies support the development of Precision Medicine.

ANGLE is collaborating with world leading cancer research institutions, such as MD Anderson and the University  of Southern California in North America, and CRUK-Manchester and UKE-Hamburg in Europe. The Parsortix  system and consumables are being sold in Europe and North America to leading cancer research groups. More  than 35 peer reviewed publications (including from Nature and Cell) highlight the insight that can be gained from a  simple blood draw about a patient’s cancer.

ANGLE has recently opened GCLP compliant labs in Guildford (UK) and Philadelphia (USA) to provide the  pharmaceutical industry with a send away service for the analysis of CTCs in patient samples from clinical trials.  Furthermore, ANGLE R&D labs will provide custom development of CTC assays for pharma – which can then be  transferred into the GCLP labs.

We offer an inclusive and welcoming culture which is firmly rooted in our commitment to develop products for  use in rare cell diagnostics that enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease.

We are currently recruiting for a Clinical Assay Development Manager. As part of the ANGLE Europe  R&D team, the Clinical Assay Development Manager is responsible for overseeing the design and validation of  novel clinical assays in biological samples for pharma services clients. This position works to support internal and  diagnostic product development programs, contributes to product innovation and drives the creation of new  intellectual property.

 

Essential Duties and Responsibilities:

  • Lead and participate in the laboratory development of custom CTC assays for biopharma clients and ANGLE  collaborators.
  • Manage transfer of developed assays into manufacturing and for ANGLE clinical laboratory deployment.
  • Develop plans and maintain procedures in accordance with ANGLE’s quality system requirements to support  quality records and regulatory filings.
  • Manage projects in a matrix structure across multidisciplinary teams (molecular biology, cell biology and imaging,  engineering, software, regulatory/clinical and quality):
    • Provide detailed, comprehensive plans and specifications for projects.
    • Identify, document and manage dependencies and risks for projects.
    • 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.
  • Support the development of manufacturing processes for packaged kits and reagents.
  • Represent ANGLE externally through support of pharma services business development activities, publications,  and presentations at academic and industry conferences.
  • Interact closely with the entire R&D team and wider company. Work with other group leaders to forecast  staffing requirements and to share and allocate resources within the R&D team.
  • Manage relationships with external organizations and collaborators as required.
  • Communicate program/project status and plans to Head of R&D.
  • Work within the New Product Development process and provide documentation and supporting evidence to  ISO13485 and 21CFR820 standards for project technical and commercial reviews.
  • Foster quality of data within the organization.
  • Write/review external scientific publications and Application Notes.
  • Contribute to laboratory record management and quality systems.
  • Undertake additional ad hoc / project work as required under the direction of the Head of R&D.

Required Experience, Education and Knowledge:

  • Master’s Level or other advanced degree in Life Sciences OR an equivalent combination of commercial experience and formal education.
  • 5-10 years’ experience in the development and transition of assays from R&D to commercialization as LDT and IVD/RUO products in a structured development environment.
  • Demonstrated knowledge of cell imaging techniques, molecular biology, protein chemistry and cell culture.
  • Experience in managing people working in a multi-disciplinary project team, including management of contract R&D, preferably in a matrix-based organization.
  • Experience in project management is essential (including but not limited to development of project timelines, budgets, and deliverables).
  • Experience in data analysis and biostatistics.
  • Experience with transfer of R&D developed assays into manufacturing, including verification and validation tasks associated with the transfer.
  • Must have experience working in a regulated environment – medical device or therapeutics.
  • 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, REACH, COSHH, GMP, GLP and QSR.
  • Experience with visual tools for project tracking, management, and reporting.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint)
  • Due to the nature of this role, the job holder is required to regularly work in the Guildford facilities (at least  one entire week in every six weeks).

Key Attributes:

  • Ability to problem-solve over a complex range of tasks subject to competing contractual, financial, personnel and time constraints.
  • Organizational skills and the ability to rapidly prioritize tasks in response to unexpected opportunities or risks.
  • Ability to manage and coordinate the timely creation and delivery of project reports. Ability to multitask and prioritize to meet deadlines.
  • Able to provide scientific mentoring and training to develop others and promote good scientific practice.
  • Demonstrated ability to manage teams from the front and through influencing skills.
  • Ability to plan staffing levels and assignments across a portfolio of projects.
  • Effective time management and an ability to delegate work to team members and manage work product delivery.
  • Demonstrable record in relationship partnering.
  • Strong scientific/technical aptitude combined with business acumen.
  • Commercially astute and a dynamic, strategic thinker.
  • Ability to summarize detailed data and form actionable recommendations for a variety of audiences.
  • An eye for detail and a commitment to high quality data.
  • Strong team player with excellent oral and written communication skills.
  • Possess a flexible, can-do approach to the requirements of the job.

How to Apply

Please submit your resume, along with a cover letter to jobsABI@angleplc.com or apply directly to our website  at https://angleplc.com/careers/ 

Please reference the position: “Clinical Assay Development Manager”.

All applications will be kept confidential. We thank all candidates for their interest, but only candidates selected  for an interview will be contacted.

At ANGLE North America Inc. we are committed to maintaining and developing a qualified workforce that  reflects the diverse population it serves, and we welcome applications from all qualified individuals. We value  diversity and we do not discriminate on the basis of race, religion, color, sex, age, non-disqualifying physical or  mental disability, national origin, sexual orientation, gender identity or expression, or any other basis covered by  local law. We are also committed to preventing and removing barriers to employment for people with disabilities,  and we invite you to inform us should you have any accessibility or accommodation needs.

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