Job DescriptionMicrobiologist IIKing of Prussia, PASummary
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 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.Responsibilities
- Collaborate with a diverse team to develop new products for cell and gene therapy applications.
- Perform microbial testing of raw materials, bulk, finished products and aseptic packaging components.
- Endotoxin and Sterility testing.
- Write and update SOP's.
- Perform Bioburden, pH, TOC, Conductivity, Osmolality.
- Plate enumeration.
- Perform Growth promotion of media.
- Aseptic Sampling of in-process samples for testing.
- 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.
- Maintain laboratory records and contribute to laboratory organization and maintenance.
- Perform and coordinate microbial testing in support of process development, cGMP investigations and product characterization.
- Reviews, interprets, and communicates data cross-functionally within the organization.
- Attend, participate in, and present results at cross-functional team meetings.
- Author reports and source documentation to support regulatory filings.
- Bachelor's Degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline
- Minimum 1-3 years' experience in pharmaceutical, Microbiology, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.
- Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbal.
- A proven ability to collaborate with team members to complete projects in an efficient and timely manner.
- Capability and desire to work in a dynamic, fast-paced, innovative environment
- Prior experience with working in a GMP lab is highly desirable.
- Prior experience with Environmental monitoring in aseptic areas is required.
- Understanding of compliance and cGMP considerations.
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