At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
Responsible for supporting microbiological programs and testing activities for processes, instruments and equipment. ensures the effective use of material, equipment and personnel while developing products and processes at high quality levels. This person is responsible for oversight of personnel supporting performing testing in support of the following programs:
Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable)
Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates)
Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests)
Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host)
Media Release
Laboratory Support
It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory a minimum of 40%.
Responsibilities:
Employee management and development.
Execute and review routine Microbial Laboratory work. Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals. May perform testing when required.
Makes detailed observations and carries out advanced data analysis.
Strong documentation and technical writing skills.
Strong understand of monitoring programs and methods and conducts troubleshooting analysis.
Qualified trainer for the Quality Microbiology team and performs training for staff on programs as needed.
Familiarity with current regulations and scientific literature.
Ensures method verifications and qualification protocols and investigations are performed appropriately. May execute testing when required.
Maintains current state of training prior to execution of tasks.
Ensures proper labeling, handling, and storage of all chemical and biohazards used in the laboratory. Ensures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training, including handling hazardous waste.
Requirements:
Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 5-7 years of technical management experience; or a master’s degree with 3 years or a Doctorate degree in Microbiology study and 1 years related experience and/or equivalent training preferred. This person will have 0 years' experience in managerial experience.
Must have knowledge of GMPs and biotechnology-derived product regulations and be able to react to change productively and handle other essential tasks as assigned.
Also requires a demonstrated track record in the following areas:
Strong orientation for Quality and Customer Service
Demonstrated level of respect for individuals
Demonstrated contribution to science in appropriate area
High level of integrity and personal responsibility
Strong Collaboration and Team building skills
Salary Range: $101,000 - $138,600
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
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KBI Biopharma Boulder, Colorado, USA Office
2500 Central Ave, Boulder, CO, United States, 80301
KBI Biopharma Louisville, Colorado, USA Office
1450 Infinite Drive, Louisville, CO, United States, 80027
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