CBM

Full Time EE

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.

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, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

The Senior/Scientist, Analytical Ultracentrifugation (AUC) position conducts and provides technical guidance on AUC or other biophysical method development and validation projects. The Senior/Scientist, AUC will perform troubleshooting for AUC and other instruments, methods, and procedures, and will be responsible for writing protocols and reports. The role will also assist others in performing routine maintenance and troubleshooting on AUC or other biophysical instruments methods and procedures. The Scientist will be required to design and execute method development/validation independently and interpret and review analytical data for self and other team members.

Responsibilities

·        Independently performs AUC development/optimization/validation and conduct routine AUC testing for AAV or other biologics products

·        Trains junior scientists in AUC or other biophysical technologies

·        Designs and executes experiments independently for self and others

·        Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents

·        Leads analytical (procedural and instrumental) troubleshooting sessions Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities

·        Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)

·        Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers 

Qualifications

·        Bachelor's degree, or equivalent and relevant previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 4 years or Master's degree with 3 years of experience or PhD with 1 year of experience

·        Demonstrated ability to apply AUC to analyze gene therapeutic products and other biologics Extensive hands-on experience in performing and trouble-shooting AUC technique, preferred using SEDFIT software for data analysis

·        Experience with other biophysical technologies is a plus Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systems

·        Ability to independently optimize analytical methods

·        Ability to independently perform root cause analysis for method investigations Proven technical writing skills Proven problem solving and troubleshooting abilities. Effective written and oral communication skills as well as presentation skills Time management and project management skills Ability to mentor others on technical operating systems Ability to independently review and understand project proposals/plans. Ability to work in a collaborative work environment with a team