Rangam · 2 days ago
RCI-ABBV-30583 Microbiology Scientist (Bioburden/Sterility Assurance/Pharmacopeia/Biologics/Method validation)
North Chicago, IL
Contract
Hybrid
Senior Level
5+ years expRangam is seeking a Microbiology Scientist to provide global microbiology support for manufacturing biologics and medical device products. The role involves supporting validations for microbiology methods, troubleshooting microbiology issues, and writing regulatory submissions while working independently to develop and optimize laboratory methods.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
Provide global microbiology support (support US and out of US MFG sites & Third party manufacturers for products)
Provide support to Mfg. biologics, parental products, combination medical device products
Supporting validations for all Microbiology methods for each and every products
Consult, troubleshooting and providing guidance, write regulatory submissions, write global submissions
Whenever there is investigation at mfg. sites team supports microbiology issues and provides guidance how investigations can be conducted or what would be the CAPA for root causes. review those investigation reports as well
Would write protocols for special tests that are not written but typically the sites will write protocol and reports and this candidate will review them
Knowledge of ISO standards
Exp ion Pharma or medical device industry is a plus
Deal with Bioburden, bacterial endotoxin test
Will not write publications
Will write submissions to FDA, EMEA or other countries
Will present data to senior leadership
Time management
Ability to prioritize
Background in microbiology at a mfg. facility
Someone who has worked in quality in mfg. site that will be helpful
Quality exp in mfg. site preferred
Technical expert that will independently investigate, identify, develop, and optimize new methods/ techniques to address critical project needs
Continuously seek to improve existing laboratory methods and processes
Read and adapt literature to accomplish assignments
Demonstrate mastery of broad range of experimental techniques and methods of data analysis
Independently design, execute and interpret critical experiments to answer scientific questions
Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond
Learn, understand, and master new experimental techniques, and act as a resource or mentor for others
Innovate and implement new experimental protocols
Demonstrate a high level of proficiency in his/her field
Set and meet experimental timelines
Effectively organize and present scientific plans and data
Contribute to writing and conceptual framework of publications, presentations, and patents
Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or pilot plant-based activities where applicable
Qualification
Required
Sterility Assurance or sterilization methods/modalities
Moist heat, dry heat, gamma irradiation, electron beam, ethylene oxide
Relevant ISO standards
Autoclave Cycle Development
Biological indicators knowledge
Depyrogenation
Aseptic process simulation or media fills
Microbiological test methods testing or validation
United states Pharmacopeia (USP) <51>, <61>, <71>. <85> or Ph Eur or JO equivalent
Bioburden, total aerobic microbial count (TAMC), Total yeasts and molds count (TYMC), bacterial endotoxins test (BET), Sterility, Antimicrobial Preservative Effectiveness, Pyrogen
Filter Retention and Microbial Viability
Experience in Pharma or medical device mfg. environment
Masters degree will work
Provide global microbiology support (support US and out of US MFG sites & Third party manufacturers for products)
Provide support to Mfg. biologics, parental products, combination medical device products
Supporting validations for all Microbiology methods for each and every products
Consult, troubleshooting and providing guidance, write regulatory submissions, write global submissions
Whenever there is investigation at mfg. sites team supports microbiology issues and provides guidance how investigations can be conducted or what would be the CAPA for root causes. review those investigation reports as well
Would write protocols for special tests that are not written but typically the sites will write protocol and reports and this candidate will review them
Knowledge of ISO standards
Deal with Bioburden, bacterial endotoxin test
Will not write publications
Will write submissions to FDA, EMEA or other countries
Will present data to senior leadership
Time management
Ability to prioritize
Background in microbiology at a mfg. facility
Someone who has worked in quality in mfg. site that will be helpful
Quality exp in mfg. site preferred
Technical expert that will independently investigate, identify, develop, and optimize new methods/ techniques to address critical project needs
Continuously seek to improve existing laboratory methods and processes
Read and adapt literature to accomplish assignments
Demonstrate mastery of broad range of experimental techniques and methods of data analysis
Independently design, execute and interpret critical experiments to answer scientific questions
Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond
Learn, understand, and master new experimental techniques, and act as a resource or mentor for others
Innovate and implement new experimental protocols
Demonstrate a high level of proficiency in his/her field
Set and meet experimental timelines
Effectively organize and present scientific plans and data
Contribute to writing and conceptual framework of publications, presentations, and patents
Routinely read and apply relevant scientific literature
Years of experience/education and/or certifications required: BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience
Demonstrated ability to independently design, execute and interpret critical experiments to answer scientific questions
Demonstrated scientific writing skills and strong verbal communication skills
Ability to multitask and work within timelines
Reading and adapting literature
Reading and applying scientific literature
Innovate and design a new experimental protocol to solve problems
Scientific writing skills
Previous experience in pharmaceutical or medical device fields
Preferred
Previous Quality or regulatory experience
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam 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 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
Company data provided by crunchbase