Technical Operations Program Manager

Cepheid - US
Job Location
Bothell, Washington, United States, 98021,
Job Description

The Technical Operations Program Manager will work in a highly dynamic environment to transfer new products/processes from development into manufacturing. The products are used for the amplification and detection of targets in Cepheid’s assay products.

The candidate will work closely with the Process Development and Manufacturing departments to schedule, coordinate, execute and monitor complex multidisciplinary projects or initiatives of various sizes and timeframes. This person will create project schedules, drive and manage projects, collect task data, and maintain updated status reports. The successful candidate will be able to manage simultaneous activities and utilize their technical skills/management talents to drive projects to completion on time and within budget.

This position will report to the Manager of Product Transfer. This position is contract with an estimated duration of 4 months.

* Facilitate the definition of project scope, goals, deliverables and limitations.
* Define project tasks and resource requirements.
* Lead the planning and implementation of projects to include gathering and documenting implementation requirements along with developing full scale project plans.
* Manage Design History Files, Risk Management Files, and project documentation.
* Plan and schedule project timelines.
* Track project deliverables using appropriate tools, monitor and report on progress of the project to all stakeholders.
* Drive action items, document program goals and risks, and communicate project status to key stakeholders.
* Coordinate between technical team, internal and external partners to establish project priority, schedule, status, and inventory requirements.
* Identify and resolve complicated issues to schedule, resources, scope and project risks.
* Generate and present reports defining project progress, problems and solutions.
* Implement and manage project changes and interventions to achieve project outputs.
* Responsible for project compliance to Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003) and product development process for aspects of a given project.
* Create and manage project schedules to ensure overall project success, emphasizing innovative solutions, value management, quality assurance, functional efficiency and stakeholder satisfaction.
* Assess the impact of projects by supporting activities that meet the respective project aims, communicating with team members regarding the project, determining measures that assess the level of project success and using external comparisons and benchmarks to establish organizational standards for project management.
* Assimilate large volumes of information from different sources and visualize/analyze relationships between parts/whole; recognize, respect and incorporate the driver ideas, perspectives and values of team members to meet organizational and project objectives.


* BS in Chemistry, Molecular Biology, Engineering, Bioengineering or relevant discipline; or equivalent combination of education and experience to perform at this level.
* 7+ years of experience in a Technical Operations setting.
* 5+ years of direct program/project management experience in Manufacturing or Engineering.
* Must have experience in managing cross-functional teams to drive complex development programs to successful milestone completion.
* Excellent communication and collaboration skills and the demonstrated ability to convey business information clearly and effectively through informal and formal documents, reports, and presentations.
* Excellent project management skills, including time and risk management and project structuring.
* Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003).
* Working knowledge and application of product lifecycle methodologies.
* Comprehensive knowledge of continuous improvement and lean manufacturing methodologies.
* Proficiency in Microsoft Word, Excel, Project and Visio is required.
* Excellent analytical thinking to include analysis, data modeling, and problem-solving skills.

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