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Senior Microbiologist

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
Job Details
PURPOSE
The Senior Microbiologist is responsible for the sterility evaluation of medical device (MD) products and combination products for safety per ISO standards and applicable regulations. The role is responsible for assisting in the design and implementation of test systems and procedures for the governance of sterility testing. The Senior Microbiologist will apply subject matter expertise to solve complex problems, utilizing technical acumen, business experience and independent judgment. This role is responsible for developing sterilization evaluation plans and reports for disposable medical device products.

The Senior Microbiologist will function as a key team member collaborating with associates from diverse technical backgrounds. They must efficiently execute sterility evaluations, testing, and reporting for product development and product life cycle management. This person will provide experience and knowledge of product safety data and procedures to support on-site and off-site Regulatory Authority audits to support product, which may be sold in various worldwide markets.
RESPONSIBILITIES
  • Develops sterilization strategies for disposable blood devices, implementing a tiered risk-based approach to establish regulatory compliance in support of new product development and registration for sterility studies.
  • Plans and manages sterilization plans, testing and/or rationales based on changes in manufacturing, supplier information, material, etc changes to medical devices.
  • Review, interpret, and summarize raw data from Contract Research Organization reports and documents biological assessments using sound scientific principles.
  • Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, and GLP.
  • The Microbiologist will be responsible for ensuring effective sterilization processes and compliance to all related standards for all Haemonetics products.
  • This position will be responsible for execution of technical strategy including writing of protocols and reports, collaboration with external sterilization resources and direct interaction with all Haemonetics manufacturing plants.
  • Timely disposition of any sterilization and environmental monitoring issues that could impact Haemonetics supply chain is a priority for this role.
  • The ideal candidate should have experience in working with EtO, Gamma, Ebeam and steam sterilization processes with full understanding of all related international standards.
  • Preferred experience with the following standards: ANSI/AAMI ST72, ISO 11135, ISO 11737, ASTM E3251, ASTM E3244, ISO 15747, ISO 11607 and European Pharmacopeia.
  • Interact closely with and provide consultative direction to Quality, R&D, Clinical, and Regulatory Affairs within Haemonetics.
  • Support on-site and off-site Regulatory Authority audits to for product that may be sold in worldwide markets.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Functional expert in the sterilization principles of disposable medical devices.
  • Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of sterility standards for blood disposable products.
  • Ability to work independently to develop, execute and document sterilization studies.
  • Proficient in Microsoft suite of applications.
  • Exhibits pro-active behavior and organizes meetings to maintain high product quality standards for all medical devices.
  • Proficient with statistics.
  • Effectively balances multiple priorities and project deliverables.
  • Ability to accurately scope projects and consider the full impact of decisions and actions taken.
  • Ability to establish and maintain effective working relationships with coworkers, managers and cross functional teams.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • 5+ years of experience with a Bachelor’s degree, 3+ years of experience with an MS degree or 1+ years’ experience with a PhD.
  • Experience in years as specified above in sterilization studies development, planning, execution and documentation.
  • Bachelor’s degree in Microbiology, Science, Engineering, Biology, Chemistry, or related degree.
PHYSICAL REQUIREMENTS
  • This job can be remote, however if close to Haemonetics office the applicant could choose to work in the office.
  • Operates in a professional office environment and routinely uses standard office equipment
  • Regular sitting for extended periods of time.
  • Extensive use of telephones and face-to-face communication requiring accurate perception of speech.
  • Occasional travel (less than 10%) may be required.
EEO Policy Statement
Conditions of Employment: Haemonetics’s requires COVID-19 vaccination for all U.S. employees who work in the presence of other colleagues or customers, unless the employee is approved for a medical or religious exemption, pursuant to applicable law. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, customers and communities as we continue to make health and safety our top priority.
Pay Transparency:
The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.
In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.
Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email
AskHR@Haemonetics.com
.
The base salary range for this role is:
$72,894.00-$98,501.00/Annual
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CEO of Haemonetics
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Christopher Simon
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Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative hematology products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses impo...

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DATE POSTED
June 10, 2023

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