Senior Microbiologist

Center for Breakthrough Medicines (CBM) 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. Our 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.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, providing employees a true community campus experience focused exclusively on life sciences.

Summary

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 flexible to support a range of projects within a fast-growing organization.

Responsibilities

• 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
• Serve as SME and Technical lead for client interactions
• Oversee 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 SOP’s
• Maintain laboratory supplies and reagents inventory
• Compile, analyze, trend data and create 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

Education & Experience

• Bachelor’s Degree in Biology, Biochemistry, Molecular Biology, Immunology, or related discipline

• 4+ years’ experience in pharmaceutical, Microbiology, or a related field with Relevant laboratory experience, pharmaceutical or biotechnology industry preferred 1+ year of experience in supervisory role

• Excellent attention to detail, strong documentation skills, and ability to communicate

• Capability and desire to work in a dynamic, fast-paced, innovative environment Prior experience with working in a GMP lab preferred Prior expertise in Sterility and Compendial testing preferred Understanding of compliance and cGMP considerations