Senior QC Microbiologist

Employer
Cresilon, Inc.
Location
New York, Iowa, US
Salary
Competitive
Posted
Jun 24, 2021
Closes
Jul 16, 2021
Ref
2284997493
Discipline
Other
Employment Type
Full time
Salary Type
Salary
Job Description
Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

1. http://www.bloomberg.com/video/vetigel-the-band-aid-of-the-future-stops-bleeding-instantly-PaIvLxjcS66F5IWO1SsKtA.html

2. http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en

Job Description

The Senior Quality Control Microbiologist (Senior Microbiologist) is a lead microbiologist at Cresilon. The Senior Microbiologist is chiefly responsible for microbiology method development, data review, engagement with regulatory authorities, and technical mentorship. The Senior Microbiologist adopts and maintains a culture of excellence and quality in all aspects of his/her job function. The Senior Microbiologist works in a highly regulated environment and aids in ensuring that the Quality Management System methods and Quality System Regulations are applied throughout Cresilon.
  • Develop, qualify and perform suitable bioburden test methods for incoming and in-process samples per USP and USP . Review data generated.
  • Develop, qualify and perform suitable incoming, in-process, and final product sterility and endotoxin testing per USP and USP , respectively. Review data generated.
  • Develop and execute environmental monitoring programs using a risk-based approach per EU GMP Annex I 2008, FDA Sterile Drug Products Produced by Aseptic Processing 2004, and ISO 14644-2:2015, as applicable. Ensure that the EM program meets regulatory and industry standards.
  • Perform and/or oversee environmental monitoring for HVAC (viable air, viable surface, total particulates), personnel monitoring and purified water (conductivity, TOC, bioburden) systems. Serve as subject matter expert in this area. Review data generated.
  • Develop and perform growth promotion testing on incoming growth media
  • Develop procedures for microbial identification and tracking.
  • Prepare and test environmental samples from all phases of the manufacturing process to verify conformance to pre-defined acceptance criteria
  • Setup, troubleshoot, and maintain equipment, including calibration.
  • Develop and execute assessments for raw material and final product long-term stability
  • Liaise with other departments including Quality Assurance, Manufacturing and Research & Development to address compliance issues and to implement corrective actions and to improve programs.
  • Perform out of specification investigations and if needed, initiate non-conformance reports
  • Develop and execute Microbiological protocols and procedures for operation, as applicable.
  • Summarize test data, maintain lot histories and analyze for trends and discrepancies and document in completion reports
  • Create or review SOPs as related to microbiology
  • Execute suitability studies, analytical method validation, including microbial sampling methods
  • Maintain and order lab supplies as needed, and participate in lab cleanup, under the supervision of the QC Director
  • Assists in bringing in additional testing capabilities to the microbiology lab as deemed necessary
  • Other duties may be assigned as deemed necessary by management

Requirements
  • Bachelor's degree in Microbiology, Biology or related scientific discipline. An advanced degree (M.S. or Ph.D) is highly preferred.
  • 10-15 years of related microbiology laboratory experience in cGMP regulated environment.
  • 9+ years with aseptic / sterile manufacturing, preferably with medical devices, biological products, vaccines or other pharmaceutical products. Extensive knowledge of validation and cleanroom technology and sterile product manufacturing required.
  • Technical expertise in USP , USP , USP , USP and USP required, including experience with performing bioburden testing, sterility testing and their qualification required.
  • Proven understanding of Raw material testing as it applies to Microbiology with an ability to assess risk based thinking/decision making coupled to patient safety.
  • Technical expertise in environmental monitoring required, including performing EM /PM.
  • Adept experimentalist with handson microbiological expertise including, gram staining, isolate identification and creating and managing a library of facility isolates.
  • Experience in room qualification (per ISO 14644) preferred.
  • Experience in cleaning validation is preferred.
  • Extensive knowledge of US and EU regulations and established expertise in interpreting and applying to organization preferred.
  • Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic and evolving environment;
  • Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
  • Mathematically inclined with demonstrated ability to analyze data with the use of appropriate statistical methodologies. Six sigma green belt or black belt certification preferred.
  • High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
  • Demonstrated ability to work independently as well as be a strong team contributor.
  • Requires excellent written and verbal communication and presentation skills. Must be able to analyze data and write summary reports
  • Proven and demonstrated computer (PC) and software skills including MS Office Suite Excel, Word and PowerPoint programs.
  • Physically able to perform Environmental Monitoring, wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

Benefits
  • Paid Vacation and Holidays
  • Medical, Dental, and Vision Insurance
  • Firm Paid Life and Short-Term Disability Coverage
  • 401(k) Retirement Savings Plan
  • Stock Options

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