Scientist II, Bioassay, Analytical Sciences

Opportunity for Secondment to AskBio

Were pleased to share an exciting secondment opportunity at AskBio.

This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years the exact duration will be based on business needs and mutual agreement.

This secondment offers a unique chance to broaden your experience expand your knowledge and contribute meaningfully to AskBios mission: to advance gene therapy and change the lives of patients around the world.

If youre interested in exploring this opportunity we encourage you to:

• Speak with your direct manager to discuss your interest and alignment with your development goals.

• Apply directly using the link provided in the posting.

We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform peoples lives.

Our principles:

Position Summary

The Scientist II Bioassay is a bench-focused individual contributor responsible for executing and developing bioassays in support of AskBios 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 AskBios Research Triangle Park facility.

This is an onsite position based in RTP NC and will report to the Associate Director Bioassay Development.

Job 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

Minimum Requirements

• Ph.D. in molecular biology biochemistry cell biology virology or related scientific discipline and 2 years of industry or related experience; OR Masters 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)

Preferred Education Experience and Skills

• 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

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race color religion gender sexual orientation gender identity national origin age disability veteran status or any other protected status prohibited under Federal State or local laws. All employment decisions are based on valid jobrelated requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website you may request a reasonable accommodation to express interest in a specific opening by calling us at or sending us an email at .