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WHAT
IN
Director Program System Development
Job
Abbott Molecular Diagnostics
US
-
Des Plaines,
Illinois
Job Code - 68443BR
Position - Full-Time
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to Abbott Molecular Diagnostics for this position!)
JOB DESCRIPTION: Director Program System Development
The Director, Program System Development will direct a major system development program including system, software and/or method/assay development and integration from concept through product launch. This individual could also direct a collection of smaller development programs which in aggregate constitute a major development effort.
Major responsibilities include:
1. Establishes, implements and maintains the internal programs as well as OEM/Co-Development programs in accordance with the quality system including quality policy, design control, CAPA and management oversight.
2. Leads the teams through the translation of customer needs into program and/or multiple project level specifications and plans. Develops program specifications for system, objectives, timelines and milestones, R&D funding process and budgets. Conceives, plans, executes and tracks the program/projects and resources to meet the strategic business needs of the division, while accommodating unforeseen events with timely and sound risk assessments and contingency plans. Oversees the analysis of data for accuracy, causes of problems and solutions to technical issues. Negotiates project outcomes and deliverables to meet the conflicting demands of quality, time, money and deadlines. Monitors actual vs. planned expenditures; analyze variances and take corrective action; make recommendations regarding project continuance.
3. Builds, inspires and continually assesses the Program Team to ensure that the Program goals and objectives are met. Leads and manages clear communication and statusing with other R&D program
director/managers, marketing director, directors of operation, directors of quality, site controller, human resources management, as well as senior management from commercial areas and divisional R&D. Manages the employee relations climate to provide a challenging, results-oriented and innovative
environment.
ACCOUNTABILITY/SCOPE:
To manage a budget with expectations to commercialize a new diagnostic system. Accountable for total R&D, successful Regulatory Clearance and manufacturing scale-up within time and budget constraints, that meet customer requirements and comply to the. May require management across multiple AM and/or OEM sites. Interacts with executive and senior level management to reach agreements regarding significant program
strategies, marketing pre-launch strategies, funding and trade-offs. Coordinates with Worldwide Marketing, Clinical Research, and Operations to integrate program/project goals with commercial, regulatory and
manufacturing goals. Assists with developing strategic business and R&D plans at the division level.
Manages (a) development team(s) which consists of senior level managers from multiple disciplines within and outside of R&D. Directs the work of a broad range of technical and support personnel; draws on technical expertise within and outside of Abbott. Coaches and mentors team members across multiple,
diverse projects on performance and development needs. Acts to develop subordinates as future managers and director candidates.
REQUIREMENTS - QUALIFICATIONS: Director Program System Development
Basic Qualifications:
Knowledge of regulations and standards affecting IVDs and Biologics.
A background in software device process is required. Technical, financial, communication and management skills required to manage diverse R&D groups within and outside of Abbott Molecular. Significant scientific and management experience with IVD or medical product(s), patent strategies and business strategy development in; reagents, systems and/or software aspects. Significant multi disciplined project management is necessary in; systems, software development, system integration and assay/methods applications along with project budgeting experience. Experience is desired in system development, manufacturing scale up for systems and reagents
Preferred Qualifications: Bachelor’s Degree - Required (life science / software / engineering background ); Master’s Degree - Highly desirable (life science / software / engineering background ); MBA, Desirable for business/financial understanding (all backgrounds)
Abbott Molecular Diagnostics
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