About Precision NanoSystems Inc. (PNI)
Precision NanoSystems Inc. (“PNI”) is a manufacturer of instruments, kits and reagents in the global nanomedicine market providing tools for drug development and cell-specific delivery to study, diagnose and treat disease. PNI’s NanoAssemblr family of instruments allow scientists to rapidly develop novel nanomedicine drug candidates for pre-clinical testing. PNI’s NanoAssemblr Scale-up platform enables the translation of these drug candidates to clinical testing and eventually to commercial use. PNI’s NanoAssemblr™ Transfection Reagents use nanomedicine technology to deliver genetic materials in primary cells vitro and in vivo, enabling disease researchers to easily study gene function in high-value models of disease. PNI sells its products to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide. Please find more information at http://www.precisionnanosystems.com/.
Position Summary
Reporting to the QC Microbiology Manager, the Senior QC Microbiology Specialist will be responsible to help establish the Microbiology group as we work towards occupancy of our Biomanufacturing Center (BMC) that is currently under construction. Initially, this role will have a primary focus on document drafting, such as the various SOPs, test methods, specifications and protocols that will define Microbiology group operations and testing to be performed at the BMC. Strong technical writing skills are required. From there, the Sr. Specialist will transition to an active and lead role within the Microbiology labs and cleanrooms at the BMC. This will include a range of sampling, testing and study execution as we work to support planned activities and timelines.
Areas of Responsibility
Draft SOPs, test methods, specifications and protocols applicable to the Microbiology group
Perform sampling and routine microbiology testing, including, but not limited to bioburden, sterility, bacterial endotoxins, microbial identification, growth promotion and particulate matter
Support method qualification and suitability activities as applicable for Microbiology lab testing
Conduct environmental, process, personnel, and utility monitoring programs to support GMP cleanroom operations and utilities
Contribute to various studies (e.g. disinfectant efficacy, settle plate and microbial recovery) to support facility and equipment cleaning and monitoring programs
Participate in the Aseptic Process Simulation program (e.g., media fills)
Prepare accurate summaries and reports, review and trend applicable monitoring data to then set appropriate alert and action limits
Mentor and train other QC Microbiology personnel on operations and testing as applicable
Follow and maintain lab cleanliness and safety standards
Conduct activities in compliance with all applicable SOPs and follow good documentation practices
Other tasks as required or assigned
Qualifications and Experience
Minimum BSc in Microbiology or related field, with at least 5 years relevant work experience in the pharmaceutical / biotechnology industry
Strong understanding of GMP compliance and compendial testing requirements
Experience in a range of testing including bioburden and sterility, BET, microbial staining and identification, growth promotion and sub-visible particulate matter
Experience with rapid / automated approaches to microbiological testing a definite asset
Must be able to gown as required to conduct cleanroom sampling activities
An excellent communicator (verbal and written)
A proven ability to troubleshoot and solve complex technical issues
Experience and ability to work with Risk Group 2 materials
Ability to handle multiple tasks in a fast-paced environment
Self-motivated and independent work ethic
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
If you’ve ever wondered what’s within you, there’s no better time to find out.