Scientist II, Bioassay, Analytical Sciences

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

1d•Onsite

About The Position

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. Position Summary The Scientist II, Bioassay is a bench-focused individual contributor responsible for executing and developing bioassays in support of AskBio’s AAV gene therapy programs. This role spans early-stage method development through GMP method qualification, supporting both characterization studies and release testing. The successful candidate will independently design, execute, troubleshoot, and optimize cell-based potency assays, immunoassays, and molecular assays, and will contribute to technical documentation including SOPs, method qualification protocols, and technical reports. This position is based on-site at AskBio’s Research Triangle Park facility. This is an onsite position based in RTP, NC and will report to the Associate Director, Bioassay Development.

Requirements

Ph.D. in molecular biology, biochemistry, cell biology, virology, or related scientific discipline and 2+ years of industry or related experience; OR Master’s degree in a related scientific discipline and 8+ years of industry or related experience
Hands-on experience with cell-based bioassays (e.g., potency, infectivity, or cytotoxicity assays) in a biologics or biopharmaceutical setting
Demonstrated experience with mammalian cell culture techniques
Proficiency in at least two of the following: ELISA/MSD immunoassays, ddPCR/qPCR molecular assays, or cell-based potency assays
Demonstrated ability to independently troubleshoot assay failures and conduct root cause investigations
Experience authoring or contributing to technical documents (SOPs, protocols, or technical reports)

Nice To Haves

Direct experience with AAV or viral vector characterization and release testing
Experience with method development through qualification or validation for biological products
Familiarity with potency-relevant data analysis tools and statistical approaches, including parallel line analysis and relative potency calculations
Understanding of GDP and GMP regulatory requirements applicable to analytical testing of biological products
Experience supporting IND-enabling or BLA-stage analytical programs
Knowledge of ICH guidelines relevant to analytical method lifecycle (e.g., ICH Q2, ICH Q14)
Prior experience mentoring or training junior laboratory staff

Responsibilities

Execute and develop cell-based potency assays for AAV vector characterization, release, and stability testing
Perform immunoassays (ELISA, MSD) for capsid titer, residual host cell protein, and other in-process and release analytes
Execute molecular assays (ddPCR, qPCR, RT-ddPCR) for genome titer, residual DNA, and encapsidation ratio determination
Independently troubleshoot assay failures; conduct root cause investigations and propose corrective actions with minimal oversight
Own method development activities from feasibility through qualification, including experimental design, optimization, and transfer to testing laboratories
Author and review technical documents including SOPs, method qualification protocols, development reports, and technical summaries suitable for regulatory submissions
Analyze and interpret bioassay data using potency-relevant statistical approaches (e.g., parallel line analysis, relative potency calculations) and present findings to the team
Support GMP method qualification and validation activities, ensuring compliance with GDP and GMP regulatory requirements
Maintain laboratory equipment, cell banks, and reagent inventories; perform routine equipment monitoring and calibration as needed
Provide informal mentoring and technical training to Research Associates and Scientist I staff
Contribute to cross-functional discussions with Process Development, Quality Control, and Translational Sciences teams as a bioassay subject matter resource