Associate Principal Scientist, Analytical Development

Found in: Appcast US C2 - 2 weeks ago

King of Prussia, United States SK pharmteco Full time

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 laboratory
  • Collaborate with a diverse team to execute assays for cell and gene therapy applications.
  • Design and Conduct cell-based and molecular assays
  • Develop 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 in
  • Collaboration with process development teams.


Requirements:

  • PhD or Masters degree in Biochemistry, Molecular Biology, Immunology or related discipline
  • 4-6 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 methods
  • Demonstrated 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 verbal
  • 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 exposure to GMP, ISO regulated environment is a desirable

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