Scientific Expert (Product Development Lead)

Recruiter
QIAGEN Ltd.
Location
London (Greater)
Posted
11 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
QIAGEN is one of the world's leading biotechnology companies. With our sample to insight solutions that unlock valuable molecular information from biological samples, QIAGEN helps to improve healthcare and safeguard our societies, enables the development of new medicines and paves the way for scientific breakthroughs. Join the revolution – and see how you can make a difference Scientific Expert (Product Development Lead) Job ID #: 8488 Functional Area: Product Management Employment Type: Regular Full-Time Duration: unlimited Location: Manchester, UK Position Description QIAGEN is a global leader in developing companion diagnostic (CDx) products with QIAGEN Manchester the centre for molecular diagnostic (MDx) applications. Working in partnership with >20 world leading pharmaceutical companies QIAGEN continues to grow its leadership in CDx development. This role will be based in the MDx Product Development department at QIAGEN Manchester and the successful candidate will take technical leadership for the development of novel companion diagnostic (CDx) assays. Working in close partnership with a pharmaceutical partner you will lead the entire development cycle, be responsible for the matrix leadership of a scientific team, represent product development within the global project core team, lead technical interaction with regulatory agencies and have a critical role managing interactions with the pharmaceutical partner. We would like to hear from candidates who want to make a meaningful contribution, and know that their success is in improving the discovery, development and delivery of healthcare. If this is what drives you, come and join our QIAGEN Team! We are hiring passionate colleagues who want to drive change through our molecular diagnostics portfolio. Product Development Leads are responsible for: Leading a matrix team of scientists to ensure technical project delivery. Responsible for technical decision within the project; technical delivery of project objectives; communicating technical status of projects; Contributing to budget management; Compliance with quality and regulatory standards. Acting in a customer facing role to provide technical expertise and relationship management to pharmaceutical partners. Working in partnership with regulatory affairs providing technical expertise in interactions with global regulatory agencies including FDA. Leadership of all aspects of CDx development (assay, software & system) from product inception through development, transfer to operations, verification, clinical trial support and product launch guaranteeing high-quality scientific delivery. Represent product development in the cross-functional core team to effectively and efficiently deliver projects. Coaching and mentoring of staff to ensure continuous development. Being a knowledge expert and thought leader for applications, diagnostic systems and development workflows. Ownership of the design history file and ensuring compliance with industry standards (e.g. CLSI guidelines, ISO standards, 21 CSR part 820). Escalation and resolution of technical project issues; technical troubleshooting and root-cause analysis within the project and ensuring appropriate corrective and preventative actions are implemented. Attending face-to-face meetings pharmaceutical partners, regulatory interactions and conferences. Position Requirements Significant diagnostic industry or academic post-doctoral experience desirable. Excellent communication and presentation skills. Experience of external stakeholder management and/or customer partnering experience desirable. Proven track record and evidence of the ability to translate knowledge into practical achievements. Proven leadership experience in medium to high complexity environments. Expert in data analysis and interpretation skills with knowledge of specific statistical tools an advantage. Expert in verbal/written communication skills with track record of tailoring communication to the target audience. Record of success as a leader with product development (CDx experience desirable). Organizational knowledge and proven successful usage of regulated quality process (e.g. design control) and completion of design-history files desirable. Essential relevant laboratory experience will include: processing biological samples; DNA/RNA extraction using manual extraction kits and/or automated instruments; Real-Time PCR manual setup and/or using automated instruments; PCR assay design. Laboratory experience in the following areas would be desirable: working in a regulated environment; infectious disease or oncology; using automated molecular diagnostic systems; next generation sequencing; advanced multiplex application; bioinformatics. Personal Requirements Decision making. Leadership. Planning and problem solving. Independent working. Focus. Communication. What we offer If this interdisciplinary challenge appeals to you, you can expect a highly motivated team that is looking forward to your support! Please apply online, quoting the reference number, with your complete application documents as well as your earliest starting date and salary expectations. We look forward to hearing from you! Appply online QIAGEN Ltd Human Resources Skelton House Street North M15 6SH Manchester United Kingdom

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