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Danaher Corporation Senior R&D Manager - CDx in Danvers, Massachusetts

Join our team of talented people who are transforming the cancer diagnostics industry! At Leica Biosystems, you will be stimulated by challenging work and inspired to learn every day. As a Leica Biosystems associate, you’ll help develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our CDx team as a Senior R&D Manager and support products you can feel passionate about!

The person in this role has accountability of the Research and Development (R&D) team, including planning and developing companion diagnostic assay (CDx) development. CDx assays and controls will be developed using immunohistochemistry and in situ hybridization technologies on the Leica Biosystems automated staining platform, BOND-III, to support the investigational drug trials of our partner pharmaceutical companies. CDx development includes early feasibility and mature projects through the product development process, including verification and validation and support of clinical trials. The successful candidate is responsible for the performance and development of employees and calibration and alignment within the R&D team. The candidate will represent the R&D group and collaborate across sites and line functions to build visibility of our excellent team to the organization.

All the responsibilities we will trust you with:

  • Accountable for technical development and rigor of all programs and ensures alignment and communication among all technical leads and visibility to R&D and management of program technical considerations and issues. Ensures consistency in program scientific development and rigor in technical and design reviews

  • Accountable for design control and process procedures and ensures all portfolio programs are compliant to quality system procedures.

  • Develops short and long-term plans for R&D resources and initiatives, including process improvement, to achieve increasing portfolio demands. Ensures resourcing and associated training available for R&D to support pre-sales, contracted and future programs and works with management to secure hiring requisitions

  • Reports and calls out to management any project technical risks / issues and revenue / business impact with identified countermeasures and support needed

  • Driving and aligning SMART performance goals within the R&D team and with business targets and identifies appropriate metrics. Together, with R&D managers ensures alignment of performance goals.

  • Defining and supporting development goals of the team and aligns with R&D managers on expectations and best practices of developing associates.

  • Ensures R&D team has access to and, support of resources and tools to advance project execution and/or efficiency and enrichment of associates. In support of associate development, leads and updates job ladder and associated comprehensive training plan.

  • Partners with R&D Managers and team to monitor R&D capacity, assess hiring needs to support short- and long-term portfolio and assess budget impact

  • Identifies important metrics and establishes targets for the R&D team, including monitoring of budget actuals to plan and addressing EHS sustainment

  • With pharma partners, represents R&D in discussions and Joint Steering Committees and tracks decisions and outcomes relative to portfolio

  • Overall management and engagement of R&D associates which includes appraisals, performance objectives, development objectives and performance management

  • Champions Danaher Business System tools and training for all of R&D, including assessing certification opportunities and gaps.

  • Laboratory management and continuous process improvement

Your areas of knowledge and expertise that matter most for this role:

  • Masters in the sciences with 8 - 10 years laboratory IHC experience in pharma or diagnostics; OR, PhD in the sciences with 7 - 9 years laboratory IHC experience in pharma or diagnostics

  • Minimum of 5 years CDx experience, including contributing to submissions to a regulatory body

  • Minimum of 5 years demonstrated ability leading teams and developing personnel and oversight of multiple programs and teams

  • Experience in leading, executing and documenting CDx assay product development, V&V using an autostainer

  • Experience in developing CDx assays and supporting clinical trials and regulatory submissions in a biotech and/or pharmaceutical company

  • Experience working in a regulated environment and under design control. Understands the validation requirements for bringing a medical device through regulatory submission in NA or EU

  • Preparing, executing and managing contracts with pharma and/or 3rd party vendors

  • Working in/with pharma partners and drug development concerns and considerations

  • In depth expertise on CLSI guidance and study design

Travel:

  • Up to 10%

What We have to Offer:

Check out our benefits here: https://danaherbenefitsinfo.com/

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time.

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Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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