Staff Development Scientist

Description Job Title: Staff Development Scientist
Requisition Number: 66555 & 66735
Location: Miami, FL, 33196

Purpose of the Position: Plan, direct and coordinate the efforts of a team of Product Development scientists to design, develop, transfer to manufacturing, verify and validate Flow Cytometry and Hematology Analyzer products. Define and translate product requirements into product designs and test performance specifications, develop technical solutions to product design and performance issues, and work with other departments within the organization to achieve project objectives and time schedules while meeting ISO and FDA regulatory and design control requirements.

Essential Duties and Responsibilities (other duties may be assigned):
• Work under the general guidance of R&D management to provide leadership of one or more Reagent Development projects from concept to launch.
• Works with Program Manager to develop, manage, update and maintain project schedules to enable accurate projection of milestone completion dates and effective prioritization of tasks and resources across the project team.
• Create and maintain the Design History File for each project under their leadership to meet the requirements specified under company Design Control policies and procedures.
• Prepare technical documents for FDA submissions.
• Plan, oversee and review the design, execution, analysis and documentation of studies performed by project team members directed toward meeting project objectives.
• Identify technical and logistic obstacles to timely completion of project objectives; work with management to identify, mobilize and direct the appropriate resources to achieve solutions to these issues.

Supervisory Responsibilities: This is a scientific project leadership position, with direct supervision of several Senior Development Scientists and/or Development Scientists. Responsible for coordinating efforts of team members from other departments to achieve project objectives.

Requirements

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Experience with design and development of flow cytometry and hematology assays for clinical diagnostics or development of pharmaceutical products in a regulated environment.
• Knowledge of FDA requirements for design control and risk analysis.
• Organizational, planning and detail follow-up skills required.
• Experience with project management and the use of project planning software.
• While this position is not a hands-on technical role, it is expected that the individual has sufficient knowledge of immunology, cell biology, hematology and/or related sciences to understand and direct the resolution of technical issues that arise during a project, including obtaining the appropriate internal or external technical expertise required and coordinating efforts needed to resolve these issues.
• Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
• Ability to handle and resolve conflicts and work under stressful conditions
• Demonstrated ability or track record of successful results
• Ability to understand complex scientific, engineering and business concepts
• Demonstrated ability to be flexible and resourceful. Excellent communication and diplomacy skills required.
• Knowledge of safety precautions required for working with blood-borne pathogens at Biosafety Level 1 and 2.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com

AN EQUAL OPPORTUNITY EMPLOYER - We believe that the mutual goals of our business and the community can best be met through our policy that consideration of race, color, religion, ancestry, national origin, sex, age, disability, veteran status or other protected characteristics, has no place in the selection, training or promotion of employees. In furtherance of this policy, we have developed a written Affirmative Action program to ensure positive action in providing equal opportunity for employees and applicants.

Apply online at: https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs=&job_REQUISITION_NUMBER=66555