|at ( view profile)|
|Date Posted||January 24, 2020|
Contract GMP Manufacturing
|Address||3230 Deming Way|
The Gene and Cell Therapy team at PPD’s GMP Laboratories in Middleton, WI support the development, validation of analytical methods that are used to support quality testing of gene and cell therapy products. These methods consist of state-of-the-art instrumentation for both molecular (qPCR, ddPCR, Sanger and deep or NextGen sequencing) and cellular (transfection/transduction; expression/function) biology applications designed to quantify and establish the identity, integrity, fidelity and potency that support demonstration of consistency and stability of a drug substance/product against the quality parameters established for these complex products. The data generated support: product development; regulatory submissions; and product lot release to meet international regulatory guidance and GMP quality system compliance requirements.
As a Senior Research Scientist with PPD's Gene and Cell Therapy Laboratory, responsibilities may include the following:
- Oversees complex bioassay development for gene and cell therapy products to create new methods, optimize existing methods, and transfer client-provided methods using cell-based assay and multiple read-out techniques (qPCR, ELISA, etc.).
- Provides technical and regulatory consulting to internal groups and clients about their programs.
- Provides technical guidance and mentorship to senior staff members in performing laboratory activities.
- Routinely acts as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.
Education and Experience:
- Bachelor's degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years’) or equivalent combination of education, training, & experience.
- Master’s degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6-8+ years)
- PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4-6+ years)
Knowledge, Skills and Abilities:
- Demonstrated Client Interaction and Project Management experience
- Proven ability in managing and coaching experienced research scientists and associated projects
- Extensive assay development experience utilizing Real-time PCR in a regulated laboratory
- Strong experience with PCR, q PCR, RT-qPCR
- Experience with Sanger and Next Generation Sequencing
- Strong experience with lab documentation and reporting
- Full understanding of laboratory requirements, SOPs, ICH guidelines and FDA guidance
- Full theoretical and hands-on understanding and knowledge of molecular biology and genomics
- Full knowledge of technical operating systems
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for method investigations
- Proven ability in technical writing skills
- Proven problem solving and troubleshooting abilities