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Senior Engineer

T2 Biosystems

Senior Engineer

Lexington, MA
Full Time
Paid
  • Responsibilities

    We are looking for a collaborative, motivated and experienced leader to take on the role of Senior Manager, Molecular Diagnostics, on our Science R&D team. The individual filling this role will be responsible for providing expertise in the areas of IVD development and molecular assay optimization.  The candidate will serve a technical role in leading studies for late stage development and verification of novel molecular diagnostic assays.  This individual will work closely with the assay development team members to develop protocols, oversee testing and produce reports. 

     

    This role will report directly to the Vice President, Science R&D, and will be a key member of our Science R&D leadership team.

     

    RESPONSIBILITIES:

     

    • Manage a small group of R&D scientists
    • Provide guidance and technical expertise to assay development staff
    • Manage completion of project deliverables and maintain timelines
    • Optimize molecular diagnostic assays to meet product requirements
    • Develop, refine, and execute protocols required for verification and validation procedures
    • Work as part of a cross-functional team to migrate assays onto instrumentation
    • Work with reagent manufacturing to transfer assay production processes
    • Serve in both technical and people-leadership roles in developing molecular diagnostic assays
    • Maintain QSR compliance of project documentation and processes
    • Lead and conduct drafting of documentation including protocols, reports, risk analyses, batch records and other project documentation

     

    SKILLS AND EXPERIENCE:

     

    • PhD in Molecular Biology or related field with 7+ years of relevant work experience
    • Proven track record in managing high-performing teams and successfully completing development projects
    • Technical expertise in molecular diagnostics and IVD assay development
    • Proven track record in the development of FDA cleared IVD assays
    • Experience in technology transfer and manufacturing procedures
    • Demonstrated experience working under design controls, risk management and QSR compliance and in developing clear work instructions, protocols, reports and other documentation.
    • Demonstrated excellence with data analyses and attention to detail
    • Successful project management experience and demonstrated ability to achieve project timelines and milestones
    • Experience supporting commercial products including root-cause investigations, corrective actions, remedial action, troubleshooting, and reagent-system interactions a plus
    • Excellent organizational, record keeping and communication skills

    Required Skills Required Experience

  • Qualifications

    As an Account Executive, you will be act as the liaison between the client partners and PureRED’s internal team, maintaining the flow of jobs. You will ensure that all customer requests are completed accurately and according to schedule for all assigned accounts.

     

    • Conduct deep discovery to ensure complete understanding of clients’ needs and expectations
    • Keep abreast of daily changes, rules and guidelines and convey as needed
    • Work with client and vendors to identify deliverables and determine scope of client creative and marketing projects (i.e. kickoff date, objectives, timelines, expectations and project metrics).
    • Work closely with internal and external contacts to adjust items and pricing based on local inventory, regional cost variations and local market initiatives while maintaining original marketing integrity of the ad
    • Drive creative projects from initial concept through file release; perform day-to-day leadership activities such as building and tracking project timelines, facilitating status meetings, and phone conferences.
    • Provide strong communication, proofreading, content management, layout and document updates.

     QUALIFICATIONS:

    • 1-4 years of experience in an Account Executive/management environment
    • Working knowledge of Microsoft Office products and Adobe Acrobat
    • Excellent proofreading and organizational skills
    • Precise attention to detail
    • Complex problem-solving abilities
    • Life-long learner mentality
    • Ability to work cross-functionally across multiple teams
    • Excellent verbal and written communication skills
    • Ability to work in a fast-paced deadline-oriented environment
    • Willingness to be flexible and adaptable with the ability to pivot if needed

    EQUAL EMPLOYMENT OPPORTUNITY The Company is an equal opportunity employer and makes all employment decisions without regard to race, color, religion, gender, marital status, disability, national origin, sexual orientation, military or veteran status, or any other classification protected by law. In addition, the Company complies with all applicable federal, state, and local laws governing non-discrimination in employment.  Decisions concerning employment are based strictly on an individual’s qualifications and ability to perform the job under consideration, the comparative qualifications and abilities of the other applicants or employees, and the individual’s past performance, if applicable, within the Company. Employment decisions include, but are not limited to, recruitment, hiring, promotions, salary or other compensation, benefits, transfers, discipline, layoffs, termination, and training.