Associate Principal Scientist, Analytical Development
📋 Role Overview & Responsibilities
Position: Associate Principal Scientist, Analytical Development
Location: King of Prussia (Onsite)
Company: SK Pharmteco
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 concept 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 Associate Principal Scientist will execute in-process analytical testing for cell and gene therapy products with a multidisciplinary Process Development team.
Responsibilities:Oversee lab activities and assays execution of junior members of the team and mentoring them.Execution of testing in development laboratoryCollaborate with a diverse team to execute assays for cell and gene therapy applications.Design and Conduct cell-based and molecular assaysDevelop presentations and communicate technical results to internal technical groups.Maintain accurate laboratory records and draft technical reports to comply with good laboratory practices. and standard operating procedures.Generate, analyze, and record high-quality data using documentation, and database tools.Maintain laboratory records and contribute to laboratory organization and maintenance.Independently execute analytical methods to characterize viral vector and cell therapy products.Perform analytical testing in support of process development, cGMP investigations and product characterization.Characterize process and product related impurities in cell product and viral vector inCollaboration with process development teams.
Requirements:PhD or Masters degree in Biochemistry, Molecular Biology, Immunology or related discipline4-6 years’ experience in cell and molecular biology, biochemistry, chemical engineering, or a related field with relevant laboratory experience, pharmaceutical or biotechnology industry preferred.Minimum 4 years of experience with assay development and qualification, including flow cytometry, ELISA, PCR-based assays (ie qPCR, dPCR, ddPCR), and/or other common analytics highly desired with emphasis on PCR methodsDemonstrated ability to conduct experiments to meet technical objectives. Excellent attention to detail, strong documentation skills, and ability to communicate technical findings effectively both written and verbalAbility 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 environmentPrior exposure to GMP, ISO regulated environment is a desirable
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This position is located in King of Prussia, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
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