Reagent Manufacturing Manager

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Reagent Manufacturing Manager

HemoSonics, LLC is seeking a Reagent Manufacturing Manager who will be responsible and accountable for reagent manufacturing for novel assays intended for use on a near POC coagulation system.   

Key Attributes of the Successful Candidate:

  • Thorough knowledge of reagent manufacturing in an FDA regulated environment to ensure activities adhere to Design Regulations as detailed in CFR 21, 820 C.
  • Proficiency in commercial software packages (project planning, data base analysis, spread sheet, word processing and presentation). High level of competency with Microsoft Word and Excel.
  • Excellent oral and written communication skills, with demonstrated ability to effectively communicate with Senior Management and BOD.
  • Ability to work in a fast-paced, entrepreneurial environment.
  • Self-starting, self-motivated and capable of high levels of independence when necessary.
  • Demonstrated leadership capabilities.
  • General understanding of Lean principles is preferred. 

Key Responsibilities:

  • Reagent Manufacturing:
    • Direct and participate in the formulation of liquid based and lyophilized coagulation reagents.
    • Oversee manufacturing of products including but limited to coagulation reagent and whole blood control products.
    • Develop and publish manufacturing schedules in conjunction with the Sr. Manager Supply Chain and Sr. Manager Operations, and the Reagent Manufacturing team.
    • Duties also requiring assistance and oversight include but are not limited to raw material selection and qualification, batch assembly, final assembly, kitting, labeling and stability assessment.
    • Work within the HemoSonics ERP system as required.
    • Work with R&D teams to schedule formulation of on-market reagents and controls, prototype batches, new product or process validation batches.
    • Interface with the engineering teams to assist in investigations, scheduling process improvement materials for cartridge or instrument testing, and other projects as they arise.
    • Work in a cross-functional team environment to resolve NC’s, deviations, if required, product transfers, scheduling, and other topics as they arise, related to reagent manufacturing.
    • Ensure the reagent manufacturing laboratory is maintained as required under an FDA regulated industry for in vitro diagnostics.
  • Ensure employees within your department are provided with enough guidance, direction, leadership, and support necessary to ensure that they are able to accomplish their goals. 

Education and Experience Required:

  • BS degree in scientific or engineering discipline and a minimum of 7 years’ experience in medical device industry.
  • Demonstrated experience successfully directing a team of scientists in a manufacturing or project team environment.

Physical Requirements:

  • May involve travel to HemoSonics facilities in North Carolina and Virginia as needed
  • Must be able to lift/carry up to 50lbs.

The position is based in Durham, NC. To apply, please submit your cover letter, resume and salary requirements using our online Application Form, or via careers@hemosonics.com.

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

 

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