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Featured Employers
R&D Manager Companion Diagnostics
Company: Leica Biosystems
Location: Danvers, MA
Employment Type: Full Time
Date Posted: 06/27/2022
Expire Date: 07/27/2022
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Sales, Science, Executive Management, Research & Development, Medical
Job Description
R&D Manager Companion Diagnostics

Leica Biosystems mission of Advancing Cancer Diagnostics, Improving Lives is at the heart of our corporate culture. Were a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.

Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, youre helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.

The Companion Diagnostics (CDx) R&D Manager has direct and over-sight responsibility for the technical assessment and development of companion diagnostic assays (CDx) using immunohistochemistry and in situ hybridization technologies on the Leica Biosystems automated staining platforms to support the oncology drug trials of our partner pharmaceutical companies. Technical assessment and development responsibilities include detailed understanding of the evaluation of assays and controls through feasibility, development, verification and validation activities and supporting design transfer for manufacturing and clinical trial execution. The successful candidate will manage the performance and development of Scientists and Senior Scientists as (project technical leads) business need develops, including supervision of CDx projects being developed by direct reports.

Major Responsibilities

  • Execution / oversight and accountability for the technical development of multiple CDx programs through all stages of the product development process in compliance with the quality system procedures and provides detailed, rigorous reviews and analysis of study design, project documentation data and conclusions to ensure on-time-delivery against contracted pharma partner timelines and achievement of revenue targets.

  • Generates and reviews contracts, costing sheets and timelines for accuracy and completeness, provides discrete input and indirectly or directly supports pre-sales activities and, post-sales, provides oversight of pharma partner and management communication and supports Senior Scientists and Scientists.

  • Works with associates and colleagues to prepare and align on resourcing plans, identify gaps and justify hiring needs to support pre-sales, contracted and future projects.

  • Supports direct reports in the preparation and management of SMART performance and development goals and conducts interim and year end assessments. Identifies associate training gaps and proposes counter measures. Mentors associates, including technical leads, on study design as well as in applying guidance documents. Owns the design control system for respective programs.

  • Supports quality system audits and manages any gaps and CAPAs to closure. Identifies cross-site quality system challenges and works with cross-site teams to address improvement opportunities

  • Identifies laboratory improvement initiatives, assesses impact and communicates improvement initiatives and proposals to gain management buy-in

  • Coaches and advocates use of Danaher Business System (DBS) tools and becomes a DBS practitioner.

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

  • Bachelors in the sciences with 7 - 9 years laboratory IHC experience in pharma or diagnostics, OR; Masters in the sciences with 6 - 8 years laboratory IHC experience in pharma or diagnostics, OR; PhD in the sciences with 4 - 6 years laboratory IHC experience in pharma or diagnostics.

  • 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

  • Able to lead teams to achieve project deliverables; Resource planning management and tracking to support multiple demands

  • Knowledge of supporting clinical trial start-up and monitoring

  • Proficient in leading, executing and documenting CDx assay product development, verification and validation using an automated staining platform preferred.

  • Experience in developing CDx assays and supporting clinical trials and regulatory submissions in diagnostics and/or pharmaceutical company helpful.

  • Experience working with and preparing Statement of Work contracts preferred.

What we offer: You can view our benefits at www.Danaherbenefitsinfo.com

#LI-KL1

When you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If youve ever wondered whats within you, theres no better time to find out.

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Company Name: Leica Biosystems
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Website: https://jobs.danaher.com/global/en/...
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