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Senior Program Manager - Companion Diagnostics- Monogram Biosciences

Company: LabCorp
Location: San Rafael
Posted on: February 13, 2020

Job Description:

Monogram Biosciences, a LabCorp company, is seeking a Senior Program Manager to join its team in South San Francisco. This position will provide Project Leadership to new and future Companion Diagnostic (CDx) Single-Laboratory-Use Assay development efforts within the framework of ISO13485/QSR-820 compliant Quality Management Systems (QMS). The primary role for this position is to lead multidisciplinary product-specific Project Core and partner with other functions through all phases of CDx product development and commercialization in the US and select OUS markets. Experience working within, building and improving ISO13485 & QSR-820 compliant product development systems is critical. Experience with other OUS quality systems requirements is highly desired. This will be an individual contributor role. Responsibilities:Facilitate and lead internal CDx Project Core Teams through all required phases of ISO14385/QSR-820 compliant product development and commercialization lifecycle. Key responsibilities are listed below:Core Team and other meeting facilitation, documentation, and follow up.Project-level documentation management including documentation ownership and review, Design History File management, design review facilitation, project schedules, and other assigned responsibilities (e.g. requirement traceability matrices)Facilitate and document required communications between internal project teams and LabCorp/Covance, Pharma sponsors, and other partners/providers.Lead through example by being constantly driven to achieve successful outcomes and meet deadlines individually, with teams and management.Participate and provide Monogram-specific project management on various client-facing projects to meet specific needs of potential markets outside of the USPartner with Quality Assurance, Regulatory, R&D, Business, and Operational leadership to implement, maintain and improve Monogram's CDx development processes and proceduresRequirements BS/BA, preferably in the sciences or other technologies. MBA or other advanced degrees a plusMinimum 8 years of ISO13485 / CFR Part 820 compliant diagnostic product development experience including at least 5 years of project management experience working with project teams and management to manage projects, establish and maintain processes, policies, and systemsIVD development experience preferred. Pharma/CDx experience desiredKnowledge of biotech assay technologies and gene/cell therapies highly desiredExcellent communication, interpersonal and influence skillsStrong computer skills, including Excel, Power Point, Project Planning and WordAbout Monogram:Monogram Biosciences, Inc. (a wholly-owned subsidiary of LabCorp), is a leader in developing and commercializing innovative diagnostic products to help guide and improve the treatment of HIV, HCV, and other viral illnesses, as well as cancer and other diseases. Monogram's services enable health care providers to optimize treatment regimens for their patients. Monogram also supports pharmaceutical companies in developing new and improved antiviral therapeutics and vaccines and targeted cancer therapeutics. Located in South San Francisco, Monogram provides an innovative and flexible work environment, where you will have the opportunity to be part of pioneering new diagnostics technologies.Shift 1ScheduleMonday - Friday

Keywords: LabCorp, San Rafael , Senior Program Manager - Companion Diagnostics- Monogram Biosciences, Executive , San Rafael, California

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