King of Prussia, PA
The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM's integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM's horizontal and vertical integration provides one source throughout a product's life cycle.
CBM's mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
The Senior Microbiologist will support the development and troubleshooting of various projects related to cell and gene therapy products. This role presents unique opportunity to grow diverse technical and intellectual skills in a highly dynamic and impactful environment. We are looking for an individual who is highly motivated by our mission and technology, is self-organized, and is flexible to support a range of projects within a fast-growing organization, must be independent, goal oriented, and able to efficiently work across multiple projects.
* Collaborate with a diverse team to develop new products for cell and gene therapy applications.
* Serve as back up for microbial testing of raw materials, bulk, finished products and aseptic packaging components.
* Serve as back up for Endotoxin and Sterility testing and method suitability development.
* Write and update SOP's.
* Back up for performing Bioburden, pH, TOC, Conductivity, Osmolality.
* Mycoplasma testing
* Microbial identification
* SME and Technical lead for client interactions
* Oversees Growth promotion of media.
* With supervision, design, execute and interpret experiments to meet department objectives.
* Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.
* Maintains laboratory supplies and reagents inventory.
* Compiles, analyzes, trends data and creates visual representations of data.
* Generate, analyze, and record high-quality data using documentation, and database tools.
* Perform and coordinate microbial testing in support of process development.
* Perform Lab investigations.
* Author reports and source documentation to support regulatory filings
* Other duties assigned per business needs.
* Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal.
* Capability and desire to work in a dynamic, fast-paced, innovative environment
* Prior experience with working in a GMP lab is highly desirable.
* Prior expertise in Sterility and Compendial testing is preferred.
* Understanding of compliance and cGMP considerations.
Education & Experience
* Bachelor's Degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline
* Minimum 4 -5 years' experience in pharmaceutical, Microbiology, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
* Minimum 1 year of experience in supervisory role.