Director/Sr Director, Analytical and Bioassays
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Director/Senior Director, Analytical and Bioassays to join the AskBio team in our Research Triangle Park (Durham), NC location and be part of our continued success!
About the role
We are seeking an experienced and highly motivated Director or Senior Director to lead the development, qualification and GxP validation of in vitro bioassays to support our preclinical and clinical gene therapy programs. The role will be responsible for leading bioassay development strategies and providing technical guidance to scientists. Additional responsibilities include representation on cross-functional development teams and support the IND/CTA and BLA/MAA/NDA submissions. This role will report to the Head of Translational Medicine.
The successful candidate will have prior supervisory experience in designing, executing and troubleshooting cell-based and/or ligand-based assays. The ideal candidate for this position is expected to be an effective team manager and mentor other members of the bioanalytical team to ensure on-time delivery and interpretation of results and to drive technical excellence within the translational medicine team.
Responsibilities & Accountabilities
Serve as SME and/or a lead scientist for development, qualification and validation of cell-based methods such as neutralizing antibody (NAb) assays, T-cell response by ELISpot, in vitro bioassays; and/ or ligand-based methods such as binding antibody (BAb) assays, pharmacokinetic (PK) assays and biomarker testing.
- Manage performance of all the assays mentioned above according to GxP guidelines and help in building GxP bioanalytical lab through drafting of SOPs and lab protocols
- Align and crystalize the needs of bioassays for each program and deliver results on time and with high quality
- Partner with stakeholders to develop and execute the bioassay strategy for each program
- Operate with internal core capabilities, supplemented with external resources for flexibility and efficiency
- Lead a group of scientists and associates to develop in vitro potency assays and other bioassays in support of preclinical- and clinical-stage development programs
- Provide guidance to design, develop, optimize, qualify, validate and transfer novel cell-based potency, immunoassays, and other bioassays to support characterization of gene therapy vectors in conformance with cGxPs
- Evaluate and implement new technologies for binding and cell-based assays to measure the potency of biological modalities such as monoclonal antibodies, multi-domain proteins and ADCs. Cultivate scientific and technology innovation
- Coordinate maintenance of inventories for critical reagents and lab supplies and ability to forecast inventory based on projected project needs
- Represent the analytics and bioassays function on cross-functional teams. The role calls for close collaboration with research, process development, manufacturing, QC and other functional groups
- Contribute to the strategy for developing mechanism of action (MOA)-based assays that impact program and regulatory submissions
- Author and review relevant preclinical, CMC and clinical sections of regulatory submissions (e.g., IND and BLA)
- Develop talent, inspire innovation and promote team building and operational excellence. Foster an open and collaborative learning and work environment
- PhD with 10+ years’ experience or MS with 15+ years of experience in cell biology, immunology, biochemistry, molecular biology or related disciplines
- Extensive hands-on experience with the design, development, optimization and qualification of cell-based potency assays, immunoassays and other bioassays to measure transgene expression levels, immunogenicity, the MOA of therapeutic candidates and relative potency
- Through understanding of GLP/GCP framework
- Hands-on experience with cytotoxicity assays (e.g., binding ELISAs, flow cytometry, cell based-proliferation, phosphorylation and reporter assay)
- Experience with current statistical approaches to evaluating potency data (e.g., parallel line analysis, determination of relative potency, USP chapters on bioassay, and design of experiments (DOE)). Extensive experience in partnering in internal and external functions to transfer and implement potency assays
- Highly competent in common software and data analysis packages (e.g., SoftMax Pro, JMP, PLA software, GraphPad Prism, Microsoft Office tools)
- Leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, as well as regulatory requirements
- Excellent critical thinking and scientific acumen with a demonstrated ability to analyze, interpret and clearly communicate complex data and the impact to program and regulatory strategy
- Proven experience in supporting regulatory submissions (INDs/CTAs, BLAs<MAA/NDA)
- Demonstrated experience recruiting, mentoring and retaining talents with an inspirational leadership style
- Excellent understanding of MOA for biologics and regulatory requirements for the safety and efficacy assessments of large molecule clinical drugs
- Strong written and verbal communication skills
- Experience working in cross-functional teams with a strong mindset of innovation and collaboration
- Post-doctoral training in bio-analytics a plus
Live an AskLife™
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