Sr Manager, Research and Development (RAD / RDEV)

This role as a Sr Manager within Research and Development (RAD / RDEV) involves overseeing and leading specific research and development activities within PDx. This includes leading a team of researchers and developers, setting strategic goals and objectives, and ensuring the successful execution of projects. The EXENT Sr Manager will be responsible for the management, in the UK and Rochester, Mn USA, off mutli-disciplinary teams focused on a nose to tail NPD and product support for our Mass Spectrometry platform EXENT and any subsequent Mass Spectrometry offerings. They will collaborate closely with project management and marketing, to ensure alignment with business objectives and customer needs. With an expectation to contribute to TBS patent portfolio, the Sr Manager, is responsible for driving innovation and identifying new opportunities for product development. All NPD will be conducted in line with the appropriate Standards and CLSI guidelines and the Sr Manager will be
expected to represent PDx in meetings with Regulatory Authorities as well as act as an SME for customer interactions.
Building on the successful launch of our IVDR compliant mass spectrometry system EXENT, with a focus on product support, new product development and continuous improvement. Spearheading the introduction of new products onto the EXENT platform, with an initial focus on M Screen and Freelite, but expanding to improved throughput through the introduction of 384 well technology (driving down COGs) and identification of new markers that would benefit from an IVD compliant MALDI Tof / LCMS solution. EXENT represents a quantum leap in the sensitivity and specificity of monoclonal gammopathy patient management, there will be tantalizing opportunities to develop out from an MALDI based platform to high throughput mass spectrometry systems. The EXENT R&D lead will coordinate activities in the UK, Rochester, Mn and external laboratories as required, as well as representing PDx mass spectrometry expertise at the highest possible level to key accounts, customers and at
national and international meetings.

A Day in the Life:New Product Development for EXENT platform, ideation, concept, feasibility and development, including the raw material, scripts, settings to be passed to Tech Ops / Verification. Collaborative work approach to minimize handover time and reliance on R&D to support VerificationSupport EXENT products in the field through a process of continuous improvement, aimed at improving reliability and COG reductionSetting targets for EXENT teams based in the UK and USA as well as third party laboratories as requiredSubject matter authority for PDx representing EXENT at all levels and in all scenarios, including but not exclusive to leadership team discussions, customer interactions, national and international conference presentationsResponsible for EXENT R&D recruitment and competency framework, the latter to be rolled out to other departments in PDxStrategic relationship management, aligned with the EXENT MSLs for LCMS / higher res reflex
testingAccountable for all aspects of EXENT R&D, including budget management, training, design specifications, without the need of senior management involvement.Right first time, on time EXENT R&D timeline delivery, reducing the NCR occurrence or providing 3rd level support for resolutionsIdentification of novel ideals, methods, responsible for adding to PDx patent portfolio around EXENTWill be communicating and influencing in negotiation processes with directors and external contactsWill have close working relationship and collaboration with external business partners, Country General Managers, MSLs, Senior Managers at HQ in Birmingham e.g.: R&D, Manufacturing, RA/QA, Technical Support, Business Development, Communications and Finance.
Reporting into HQ in Birmingham, this is an office-based role with expectation of 5 days per week in the office (within the specified location) when not travelling, travel will be required to support USA based laboratory operations. Evening and weekend working may be required.
Global impact on PDX New Product delivery and support for products in manufacture and in the field.

·PhD in Chemistry, Biochemistry, Immunology, or Biological Sciences
·BSc in Chemistry, Biochemistry, Immunology, or Biological Sciences
Experience
·>10 years of relevant experience, including minimum 7 years work experience in product manufacture, R&D or a related discipline.
·Minimum 7 years of people / matrix management experience.
·Demonstrated experience in R&D new product introduction under a compliant design control system.
·Mass spectrometry method development, liquid handling script development and compliant software regression analysis expertise through to IVD compliant assay release.
·Budget management.

Knowledge, Skills, AbilitiesDemonstrated proficiency in mass spectrometry, liquid handling and software integration Demonstrated proficiency in IVD compliant product launchDemonstrated proficiency in antibody characterization, stabilization for use in IVD assaysAbility to communicate at all levels and with all media types, including scientific publications, report writing, etc. Focus on scientific presentations and publicationsComplex , multi discipline team management or matrix management, management of complex teams >10 personal in sizeDemonstrated proficiency in process improvement.Working knowledge of project management software tools such as Microsoft Project, Excel, SmartSheet and other relevant applicationsExcellent analytical and problem-solving skills.Excellent customer relationship and interpersonal skillsAbility to work under pressure and make hard decisions required to achieve project objectives.Demonstrated ability to operate independently, to take
initiative, be resourceful, and exercise astute business judgment to drive performance.Ability to lead by influence and drive stakeholder alignment.Must have excellent interpersonal, verbal, and written presentation skills in English.Demonstrated ability to champion customer needs and translate into compelling customer value.Extensive knowledge of MS Office applications is required.International experience is required, as well as demonstrated cultural awareness.Demonstrated drive, enthusiasm, and intensity with purpose.Desired experience implementing process/project-management techniques are strongly preferred.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Our work in specialty diagnostics - from providing diagnostic assays and instruments to clinical monitoring across disease stages - improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on - now and in the future.

Birmingham- Hybrid
The Binding Site Group, part of Thermo Fisher Scientific, is a global leader in specialty diagnostics, provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site's Freelite® offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit www.bindingsite.com, Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.