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 Principal Scientist, Bioanalytical, will report to the Director,Translational Biomarkers, and will serve as a subject matter expert within the department to guide the design, qualification, and validation of biodistribution, viral shedding, and functional studies in support of pre-clinical and clinical stage programs. In concert with and in support of the Director,Translational Biomarkers, this individual will contribute to the overall day-to-day activities of the bioanalytical and bioassays group; including reviewing program and project data, providing regulatory guidance for assay qualification and validation in line with published documents, functioning as a technical lead for critical assays, serving as a member of internal project teams, and supporting the development and mentorship of junior members of the bioanalytical and bioassays group.

This position will be located at AskBio’s headquarters facility in RTP (Durham), NC.

Job Responsibilities

• Design, Direct and Execute the implementation of bioanalytical assays to investigate biodistribution, viral shedding, and functional assessments for candidate and clinical stage gene therapy programs

  • Expertise in molecular assays including dd-PCR, RT-ddPCR, ELISA and MSD

  • Technical knowledge of assay requirements for qualification and validation including defining assay parameters & optimizing protocols

• Manage execution of preclinical and clinical activities on multiple projects and initiatives with an emphasis on cutting edge techniques to support the advancement of early stage programs and to support phase appropriate activities for clinical trials

  • Work with TM project leads and Director, Translational Biomarkers of prioritization of study activities and adherence to deliverables across programs

• Oversee the execution of work to ensure operational team is meeting study compliance for performed activites

• Hands-on technical leadership and mentorship of research associates, analysts, and junior scientists

• Author and review assay validation protocols, reports and SOPs prior to submission to Quality Assurance (QA).

• Serve as SME for internal and external bioanalytical assay strategy and data interpretation including the support of CRO and other relevant outsourced activities.

• Collaborate with biomarkers, histology, and in vivo teams on the development of novel assays and strategies to support accelerated approval for clinical programs

Minimum Requirements

• Ph.D in cell biology, molecular biology, or related scientific fields required with a minimum of 8 years' relevant experience (may include post-doctoral work)

• Demonstrated expertise in bioanalytical assays including dd-PCR, RT-ddPCR, ELISA, MSD, and other biomarker/bioassay platforms

• In-depth knowledge of FDA regulatory guidance on potency assay, bioanalytical development and industry best practices

• Experience in directing the development and validation of molecular, protein, and cell-based assays

• Established leadership experience in both project and people management

• Ability to achieve objectives/timelines through collaborative efforts with coworkers, and managers

• Excellent communication, interpersonal, organizational, and multi-tasking skills

• Ability to work independently and have good attention to detail

Preferred Education, Experience and Skills

• Experience with AAV, cell & gene therapies drug discovery and development

• Strong understanding of FDA, EMA, and ICH regulatory guidance in drug development and in-depth understanding of GLP guidelines internationally

• Analytical and problem-solving skills used to lead troubleshooting in all areas of preclinical and clinical development

• Proven track record serving as a subject matter expert in bioanalytical and bioassays development and implementation complemented by a robust record of written scientific expertise

• Excellent presentation skills with the ability to efficiently relay information to project teams and other key stakeholders

• Ability to develop relationships in a matrix environment and comfortable communicating with sector leads and key stakeholders to ensure that project, scientific and resource demands are aligned

• Proven ability to work independently and be self-motivated

• Flexibility to work across multiple projects in a fast-paced environment while adhering to deliverable timelines to facilitate advancement of internal programs

• History of collaboration across multiple functions to facilitate the conception and advancement of bioassay and/or biomarker approaches

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 job‐related 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 (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.