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 rAAV Vector Engineering Sr. Scientist is involved in the execution of recombinant adeno-associated viral vector (rAAV) production processes. The Sr. Scientist will participate in research to develop AAV vectors, vector engineering, Proof of concept (POC) studies, execute experiments, develop protocols and relevant supporting documentation. The Sr. Scientist position requires experience with molecular biology, biochemistry and gene expression analyses

Responsibilities

Conducting gene editing vector design, molecular cloning, plasmid prep, and sequencing

• Conducting AAV vector engineering and production

• Conducting various assays to validate and screen plasmid constructs

• Screening of genetic elements and design of next generation rAAV molecular expression systems

• Contribute to experimental design, data analysis, and report

• Maintain detailed and well-organized documentation with best industry practice

• Self-motivated and a passion for working in gene therapy

• Implementing plasmid engineering strategies to develop improved AAV production for gene therapy purposes.

• Experience with design, execution and data analysis related to experimental studies utilizing in vitro models.

• Collaborating with other Process Development Scientists at Spark to design and conduct in vitro studies to optimize development of expression vectors

• Participating in joint programs and collaborations with external parties.

• Writing study reports, manuscripts, technical reports and present results at appropriate scientific meetings.

• Preparing and reviewing process development protocols, data analysis summaries, technical reports, and other relevant process documentation.

• Maintaining an accurate laboratory notebook.

• Ensuring work conforms to applicable quality and safety standards.

• Successful training of colleagues on various experimental assays

• Participating on project teams (as needed).

 knowledge of AAV vector design is a must.

Qualifications

 Prior experience with gene editing technologies (e.g., CRISPR/Cas9, TALEN, ZFN, etc)

• Experience in culturing mammalian cell lines and transfection.

• Experienced in advanced lab techniques such as plasmid design and construction, molecular cloning, protein expression, qPCR, cell culture, ELISA, plate-based luciferase and/or enzymatic activity assays, SDS-PAGE/western blotting, gene expression assays, etc.

• Knowledge of Next Generation Sequencing techniques is preferred

• General knowledge of regulatory requirements for GMP manufacturing of biologics or gene therapy vectors are preferred, but not required

• Familiarity with designing genetic control elements using a combination of molecular, cellular and in vitro techniques.

• Strong analytical skills and problem-solving capabilities.

• Proven ability to work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

• Working knowledge of state-of-the-art principles, technologies, and instrumentation.

• Excellent communication skills (verbal, written, interpersonal). Must be able to draft protocols and technical reports, and provide effective technical presentations.

• Ability to work collaboratively across a development environment with cross-functional teams.

• Maintain relevant laboratory supplies and equipment as needed

• Adaptability to emerging project/priority needs.

• Analytical and problem-solving skills.

• Ability to manage time effectively.

• Ability to communicate and negotiate with vendors in a strategic manner.

• Ability to work well under pressure and meet deadlines.

• Proficiency in MS Office, JMP, Phyton and R/RStudio is a plus.

Education & Experience

Education and Experience Requirements

• Ph.D. in Biology, Molecular Biology, Microbiology, Virology, Biochemistry, Chemistry, Chemical Engineering or related discipline with 3-5 years of relevant experience.

• B.S./M.S. in Biology, Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline with 6-8 years of relevant experience

• Extensive hands-on experience in gene and vector editing, and transcriptional and translational analysis.

• Proficient in sub-cloning, transfection, Western, ELISA, PCR, and qPCR techniques

• Experience with viral vector production is preferred but not required.