The Sr. Quality Control Microbiologist will support method transfer, method qualification, method suitability testing, validation and routine testing of microbiological assays. This role will coordinate the development and implementation of new programs that govern general and microbiology specific laboratory practices, lead OOS and Alert / Action Investigations, generate deviation documentation and trend reports, and assist with audit preparation and participation. He or she will create, review and revise SOP’s, reports, technical documents, and attend cross-functional team meetings as a QC Microbiology representative, as well as perform peer review of microbiological data and test results from internal testing and testing performed at contract laboratories. In addition, the Sr. Quality Control Microbiologist will perform cGMP testing to support microbiological testing of raw materials, in-process, finished product, and stability samples. Testing will include, but is not limited to: ID/gram stain testing, environmental monitoring and plate reads, gowning qualification, sterility, endotoxin, and Microbial Limits / bioburden. He or she will ensure compliance with current regulatory requirements (USP, EU, ISO, ICH and FDA guidance), good documentation practices (cGDP) and industry best practices for manufacturing (cGMP).
Create and revise SOP’s/forms/reports, generate OOS and Alert/Action Investigations, initiate deviation investigations, track and trend microbiological data, attend meetings as QC Microbiology representative, assist with audit preparation and participation, peer review of microbiological test results and data from internal testing and testing performed at contract laboratories.
Develop and Implement new Microbiological Programs, support method transfer and method qualification/suitability
Perform cGMP testing such as Endotoxin/Bioburden/Growth Promotion Testing & Reads
Gown Qualification, Environmental Monitoring and Plate Reads, Documentation and Data Review, Gram Staining and Identifications
Hands on experience sampling in Clean Room environments.
Hands on experience utilizing aseptic technique and training others in aseptic technique.
Experience with data review and presenting results to functional management in a timely manner.
Must have previous involvement maintaining an audit ready laboratory.
Experience creating/revising/reviewing Microbiological SOP’s, Technical Documents, Investigations, and Protocols required
Experience with biologic products a plus.
About Spark Therapeutics
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.