Manager, Reagent Manufacturing

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Manager, Reagent Manufacturing

Durham, NC

October 2021

HemoSonics, LLC is seeking a Reagent Manufacturing Manager who will be responsible for the reagent manufacturing for novel assays intended for use on our near point of care 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, spreadsheets, word processing and presentations). High level of competency with Microsoft Word and Excel.
  • Excellent oral and written communication skills, with demonstrated ability to effectively communicate with Senior Management.
  • Ability to work in a fast-paced, entrepreneurial environment.
  • Self-starting, self-motivated, resilient and capable of high levels of independence when necessary.
  • Demonstrated leadership and people management capabilities.
  • General understanding of Lean principles is preferred.

Key Responsibilities:

  • 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.
  • Coordinate with R&D and Manufacturing Technology 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 related to reagent manufacturing as they arise.
  • Ensure the reagent manufacturing laboratory is maintained as required in an FDA-regulated industry for in vitro diagnostics.
  • Ensure employees within your department are provided with enough guidance, direction, leadership, and support necessary to accomplish their goals.

Education and Experience Required:

  • Bachelor’s Degree in Science, Engineering or other related discipline and 5+ years of related experience in the medical device industry; or equivalent combination of skills and experience.
  • Demonstrated experience successfully managing a team of technicians or scientists in a manufacturing or project team environment.

The position is based at our facility in Durham, NC and may involve travel to our HemoSonics facility in Virginia as needed. HemoSonics requires employees to be fully vaccinated against COVID-19 or meet the requirements for a medical or religious exemption as covered by the ADA or Title VII.

To apply, please email your cover letter, resume and salary requirements to:

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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