Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a
Principal Scientist, In-vivo CAR-T Potency Method Development to be located in
Malvern, PA. You will be responsible for:- Leading in-vivo CAR-T potency strategy design and implementation
- Leading method development, validation, tech transfer, and lifecycle support activities for in-vivo CAR-T products
- Work collaboratively in a matrix environment, supporting and mentoring team members.
- Supporting regulatory filings, including INDs and BLAs.
- Representing the department on cross-functional and external teams and act as a technical expert on potency.
- Communicating complex technical concepts to partners.
- Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements.
Qualifications / Requirements:- PhD with 2 years of pharmaceutical or related industry experience in addition to a post-doctoral experience is required; OR a BS or MS in a relevant scientific discipline with at least 5 years of pharmaceutical or related industry experience is required.
- Experience with in-vivo CAR-T is required
- Extensive experience in cell-based potency method development for viruses and cell therapies, including assay design and method robustness is required.
- Extensive experience in potency strategies for cell and gene therapies and regulatory recommendations.
- Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2) is required.
- Strong analytical problem solving, planning and organizational skills are required.
#LI-Onsite
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research
