Project Manager - Diagnostics Development Process, cGMP manufacturing

Diagnostics Development Process, cGMP manufacturing
Contract W2, 23
Market
Work from home not available Travel not required

Job Description


Job Description:

SMCI is seeking a Project Manager to manage projects and alliances with key in vitro diagnostic (IVD) partners that are critical to transitioning biomarker tests from exploratory through clinical trial phases to prepare commercialization of in-vitro-diagnostics tests.

The Project Manager will work closely with cross-functional leads such as diagnostics technical leads, regulatory leads and clinical operations leads, and will be responsible for managing the partnership lifecycle, including the formation of governance structures, maintaining and growing strategic alignment during the diagnostics research and development phases.

Key responsibilities:
  • Operationalize joint project teams and, administer the joint governance structure as contractually agreed
  • Manage project-specific day-to-day activities, including leading joint project team meetings between Amgen and Diagnostic partners and, if needed, testing labs, and facilitate identification of effective solutions for a range of issues including but not limited to technical, operational, budgetary, and regulatory issues
  • Serve as the primary point of communication for diagnostic partners, facilitating efficient and effective communication with the partner and aiming at strengthening individual and organizational relationships between the companies
  • Identify areas of discordant expectations between organizations and align expectations and deliverables
  • Escalate internal or external issues that cause a missed milestone/deliverable or could damage partnership health
  • Monitor results against key performance indicators and communicate results internally

    Basic Qualifications:
    Master's degree in a scientific discipline with a minimum of 3 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics technical development and/or preparation of regulatory filings
    Or
    Bachelor's degree in a scientific discipline with a minimum of 5 years industry experience in a diagnostic, or contract research organization focusing on Companion Diagnostics (CDx) or In Vitro Diagnostics technical development and/or preparation of regulatory filings

    Preferred Qualifications:
  • Advanced degree with a minimum of 3 years of industry experience in developing and/or manufacturing diagnostic assays, or in clinical operations for or involving a diagnostic test, or other role involving significant technical development in a partnership
  • Preference for candidates with experience in oncology diagnostic tests, the diagnostics development process, cGMP manufacturing, and knowledge of US regulatory submission process (PMAs and 510(k)), or regulatory submission processes outside of the US
  • Demonstrated project management experience, with the ability to lead multiple activities and resources while maintaining attention to detail
  • Good knowledge of diagnostic technologies, including immunohistochemistry (IHC), Next Generation Sequencing (NGS), Flow Cytometry and/or immunoassay
  • Anticipates partnering and operational issues
  • Strong understanding of pharmaceutical and diagnostic development phases
  • Ability to lead, align, motivate, cross-functional, and geographically dispersed stakeholders
  • Proficient in MS Office suite, SharePoint Online, and Smartsheet
  • Strong analytical and problem-solving skills
  • Self-directed, innovative and collaborative spirit, flexible to adapt to a dynamic environment, and resourceful
  • Ability to travel (up to 10% of time)
    Required Skills: DIAGNOSTICS DEVELOPMENT PROCESS, CGMP MANUFACTURING.

    Don't hesitate! Submit your resume today.

    SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm.

    (No third parties, please)
    (H1 sponsorship currently unavailable)
    (Local candidates only, please)
  • Posted By

    SMCI Glendale

    Dice Id : smci
    Position Id : A190954
    Originally Posted : 1 month ago
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