Senior Manager, Reagent Research and Development

Beckman Coulter - Diagnostics - Miami, FL (30+ days ago)3.7


Senior Manager, Reagent Research and Development - BEC010935
About Us
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.

We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.

Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.

Description

The Senior Manager, Development Science Hematology Reagents, is responsible for the strategic and operational leadership of the Reagent R&D group in Miami. This position will manage and control complex and diverse reagent development efforts. It oversees the design, development, verification and validation of the reagent design to ensure the timely completion of products at projected costs within specified performance parameters through the entire product life cycle. Such studies include system performance testing in various prototype phases, product design verification and validation studies, in support of regulatory submissions, benchmarking studies against competitive production offerings, product evaluations and any other studies or special assignments.

Job Responsibilities

•Build and develop a reagent development capability (reagents, controls and calibrators) including manufacturing requirements for Hematology products.
•Recruits and develop a high performing reagent development team.
•Participates in multifunctional technical teams and maintains strong collaborative development partnerships across the business unit.
•Ensure all FDA, ISO and related regulatory requirements are consistently met for the design and laboratories.
•Drives and oversees the development of new consumable products including transfer into manufacturing. Collaborates with R&D engineering teams in evaluating the system performance at various prototype phases.
•Participates in strategic planning processes and ensures the quality of existing products.
•Supports the integration of reagents on to the different instrument platforms. Leads various V&V studies, as well as performance testing of prototype units for the next generation hematology systems.
•Applies sound bio-statistical principles; designs and conducts meaningful clinical and/or analytical experiments; reviews and interprets experimental data in support of statistically significant conclusions and summarizes such conclusions for the research and development teams and management.
•Staff management: oversees the day-to-day function of the Reagent Development and Microbiology Laboratories, including execution according to project priorities, adequate data acquisition, GLP’s, data reduction and cogent technical reports. Evaluates staff proficiency, manages performance and provides training.
•Enforces Good Laboratory Practices ensuring data integrity, adequate specimen/sample traceability and preservation, adequate selection, certification, validation and maintenance of commercial testing equipment as required to ensure exceptional quality of laboratory services.
• Implements quality control and quality assurance procedures compliant with FAQ-QSR’s, ISO and other regulatory guidelines or protocols applicable to the product under evaluation. Expeditious documentation of corrective and preventive actions is a must.
•Trains laboratory personnel and/or peers in formulation/application processes, procedures and analysis techniques to ensure the personnel understanding the fundamental principles, techniques and the expectations in the results.
•Writes, amends, reviews, and implements SOPs for the Reagent Development and Microbiology laboratories to ensure compliance with regulatory policies and Beckman’s SOPs.
•Maintains professional expertise through literature, courses, seminars and training to ensure expertise is kept current.
•Represents Beckman Coulter in scientific and clinical forums, as required.
•Develops solid understanding of Danaher Business System tools and applies to day-to-day work

Qualifications

Bachelor degree in Chemistry, Biochemistry, Medical Technology or related field with no less than 12+ years of experience, or Master’s degree with 8+ years, or PhD degree with 6+ years in medical device or IVD industry.

•Proven prior experience leading a R&D testing or clinical team in a management role. Responsible for all aspects of product development including: technical design, budgeting, timelines, staffing through design, verification, validation and design transfer.

•Prior management experience in GLP labs and/or hospital/clinical labs a plus.

•Prior working experience in one of the following fields: Hematology, Urinalysis, Body Fluids, or Flow Cytometry – highly desirable.

•Familiarity of hematology or other cellular assay methods: volumetric, colorimetric, fluorescence, multi-angle light scattering and imaging, etc

•Knowledge and experience in cell fixatives, cell stabilization agents, osmolytes, surfactants, lysing agents, antibiotic/antifungal agents, enzymatic cleaner, and DNA/RNA staining dyes

•Reagents preparation practice at both small- and large production scale

•Experience in developing and manufacturing concentrated reagents

•Characterization of reagent performance at bench- and system level

•Development of reagent specifications and manufacturing release tests

•Experience in reagent stability, microbial, shipping and material compatibility tests

•Knowledge and experience in hematology or other cellular controls

•Demonstrated track record of developing organizational capability. Personally accountable and takes ownership. Accurately assess organizational strengths and development needs based on business strategy and work with other managers to address gaps.

•Lead and develop people and drive their engagement.

•Demonstrate deep knowledge of reagent development, characterizing key performance indicators for reagent functionality and key raw material and process characterization. Also has excellent knowledge of reagent transfer into operations.

•Possess a broad knowledge of surrounding areas including System Engineering, Quality, Regulatory & Compliance, Manufacturing and Product Management. Promote collaboration and communication between R&D departments.

•Support post launch activities to resolve performance issues

•Stays abreast of key issues and trends utilizing internal and external contacts. Maintain knowledge of industry principles and advancements.

•Publish articles in scientific journals and product patentable work as needed.

Personal Skills/ Attributes

•Critical thinker able to address complex situation and issues.
•Strong theoretical and applied knowledge of clinical laboratory methods/applications and development, validation and stability testing.
•Knowledge and experience with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Medical Device (class II) and FDA submission.
•Demonstrated experience with objective setting, performance evaluations, compensation, coaching and mentoring is highly desirable.
•Knowledge and experience with ICH/CLSI guidelines and standards especially as applied to analytical method validation..
•Proven track of record in launching products and delivering key milestones.
•Familiarity of entire product development cycle is a must. Design Control experience.
•Proven ability to develop a culture of teamwork and willingness to roll up their sleeves to get the job done.
•Multidisciplinary experience overseeing Development and Program/Project Management.
•History of driving project execution and timely delivery while ensuring a quality focus.
•Ability to work well with people and be both highly motivated and motivating.
•Ability to make difficult decisions based on the business needs.
•Ability to work in a fast-paced, and often ambiguous environment where continuous improvement is a way of life.
•Excellent communication skills. Ability to interface with various internal and external stakeholders. Ability to present milestones and stage gates to senior executives.
•Experience in medical device design & development a plus.
•Ability to travel as needed
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Organization : Beckman Coulter - Diagnostics
Job Function : Science
Primary Location : North America-North America-United States-FL-Miami

Schedule : Full-time