Tolmar · 2 months ago
Microbiology Development and Technical Specialist (Onsite)
Fort Collins, Colorado, United States
Full-time
Onsite
Mid, Senior Level
$94K/yr - $104K/yr
5+ years expTolmar is a company focused on pharmaceutical development, and they are seeking a Microbiology Development and Technical Specialist. This role is primarily responsible for performing development activities for the Microbiology Laboratory and providing technical expertise for microbiological testing and compliance with regulatory requirements.
BiotechnologyHealth CareManufacturing
Responsibilities
Serve as Microbiological investigator providing technical expertise for raw materials, component, finished product, water bioburden, environmental monitoring, and endotoxin testing
Provide position/risk assessment papers, as required
Represent the Microbiology department and provide expertise when responding to governmental authorities and marketing partners during inspections
Continually assess development systems and procedures in the laboratory to assure they comply with business directives, cGMPs, applicable cGLPs and current industry practices
Investigate antimicrobial properties of new drugs and new products
Provide expertise for sterilization, sterility, and packaging issues
Assist with interpretations of bacterial and fungal identifications and keep personnel technologically informed of new microbiology and regulatory developments
Develop methods for development projects and new products
Maintain up-to-date knowledge with FDA regulations and applicable pharmacopeias in areas where product might be marketed
Audit contract service suppliers
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Microbiology or closely related field with 5 or more years of Pharmaceutical laboratory work experience required
Knowledge of pharmaceutical, food and cosmetic, and clinical microbiology in order to interpret the impact and relative importance of microorganisms when they are isolated from raw materials, component, finished product, water bioburden, and environmental monitoring samples
Demonstrated technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors
Skill in problem solving
Ability to manage multiple projects concurrently and under tight time constraints
Ability to clearly communicate (verbal & written) and work well with employees at all levels
Ability to be organized and self-directed
Ability to function as a team member and independently
Ability to use specialized computer software such as spreadsheets and graphing software
Ability to fluently and clearly write lab notebooks, reports, and regulatory submissions
Preferred
Master's in Microbiology or closely related field preferred, with 3 or more years of Pharmaceutical laboratory work experience required
PhD in Microbiology or closely related field preferred, with 1 or more years of Pharmaceutical laboratory work experience required
Mechanical/electrical ability to effect minor instrument repairs is preferred
Experience with aseptic processing, and sterility testing preferred
Benefits
Bonus Eligible
Benefits information: <https://www.tolmar.com/careers/employee-benefits>
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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