Purification Development Senior Scientist

Genentech•Philadelphia, PA

33d•$105,000 - $195,000

About The Position

The Opportunity We are seeking a highly motivated and skilled Senior Scientist to be an instrumental contributor in the development and implementation of robust and scalable purification processes for Adeno-associated viruses (AAVs), essential vectors in gene therapy. This role requires deep, hands-on expertise in downstream processing, including various chromatography and filtration techniques. The Senior Scientist will be responsible for designing and independently executing complex process development experiments, analyzing critical data, and providing technical guidance to research associates to ensure successful, high-yield, and high-purity AAV vector production. What You'll Do Process Execution and Optimization Design and execute advanced experiments for AAV purification process development, focusing on maximizing yield and purity while maintaining vector integrity. Independently implement and optimize various downstream techniques, including affinity, ion exchange (IEX), and hydrophobic interaction chromatography (HIC), as well as depth filtration and tangential flow filtration (TFF/UFDF). Analyze process performance data, identify critical process parameters (CPPs), and implement process improvements based on scientific rationale. Technology Evaluation and Implementation Actively participate in the investigation and evaluation of novel purification resins, membranes, and high-throughput screening tools to enhance process efficiency and throughput. Design and execute feasibility studies for integrating new technologies into existing process platforms. Scale-Up and Technology Transfer Support Execute scale-up and process characterization experiments for optimized AAV purification processes in preparation for GMP manufacturing. Provide detailed technical support during the technology transfer of purification processes to pilot or manufacturing facilities. Mentorship and Technical Guidance Serve as a subject matter expert in AAV purification for the team. Provide training and mentorship to junior scientists and research associates, overseeing their experimental execution and data analysis. Troubleshooting and Documentation Independently identify and resolve technical challenges and root causes related to process performance variability, impurity clearance, and yield losses. Generate comprehensive technical reports, detailed batch records, and presentations to effectively communicate experimental design, results, and conclusions to internal stakeholders.

Requirements

You have a Ph.D. in Chemical Engineering, Biochemical Engineering, Virology or a closely related field with 4+ years of relevant industry experience in viral vector or protein purification, with a strong focus on AAV downstream process development.
You can also have a Master's or Bachelor's degree with 10+ years of relevant industry experience in the purification of complex biologics, with significant recent experience in AAV vectors.
You have expert, hands-on knowledge in operating and developing chromatographic (AKTA) and filtration (TFF/UFDF) systems.
You have a demonstrated understanding of critical analytical methods used for AAV characterization (e.g., qPCR, DLS, ELISA, SDS-PAGE, Western Blot).
You have a solid knowledge of cGMP principles and quality by design (QbD) concepts as they apply to process development.
You have a proven ability to work independently, manage multiple projects, and deliver results under tight timelines.
You have excellent written and verbal communication skills, including the ability to present complex technical data clearly and concisely.
You have a demonstrated ability to mentor peers and direct the work of research associates.

Responsibilities

Design and execute advanced experiments for AAV purification process development, focusing on maximizing yield and purity while maintaining vector integrity.
Independently implement and optimize various downstream techniques, including affinity, ion exchange (IEX), and hydrophobic interaction chromatography (HIC), as well as depth filtration and tangential flow filtration (TFF/UFDF).
Analyze process performance data, identify critical process parameters (CPPs), and implement process improvements based on scientific rationale.
Actively participate in the investigation and evaluation of novel purification resins, membranes, and high-throughput screening tools to enhance process efficiency and throughput.
Design and execute feasibility studies for integrating new technologies into existing process platforms.
Execute scale-up and process characterization experiments for optimized AAV purification processes in preparation for GMP manufacturing.
Provide detailed technical support during the technology transfer of purification processes to pilot or manufacturing facilities.
Serve as a subject matter expert in AAV purification for the team.
Provide training and mentorship to junior scientists and research associates, overseeing their experimental execution and data analysis.
Independently identify and resolve technical challenges and root causes related to process performance variability, impurity clearance, and yield losses.
Generate comprehensive technical reports, detailed batch records, and presentations to effectively communicate experimental design, results, and conclusions to internal stakeholders.