Sr. Scientist, Bioanalysis Lead

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 Sr. Scientist, Bioanalysis Lead reporting to Sr. Director, Bioanalysis and Bioassays will lead bioanalysis assay support for AskBio's gene therapy programs. This role involves developing bioanalysis strategies and plans for therapeutics at various stages of development.

Key responsibilities include serving as a SME in assay design, development, troubleshooting, validation, and GCP/GLP regulated testing. The candidate will independently develop and optimize ddPCR/RT-ddPCR assays and other plate-based assays, while also reviewing bioanalytical data and protocols.

This role will participate in project team meetings, author sections of regulatory submissions, and manage relationships with CROs for outsourced assay qualification and testing. Staying current with bioanalytical methods and regulatory guidance is essential for this role.

This is an onsite position located in RTP, North Carolina.

Job Responsibilities

• Serve as the bioanalysis representative, lead and coordinate the Bioanalysis assay support for AskBio's gene therapy programs.
• Develop bioanalysis strategies and detailed bioanalysis development plans for therapeutics at various stages of development to support drug development programs.
• Serve as a SME and/or lead scientist, lead and manage the internal and external bioanalysis assay design, development, troubleshooting, transferring, validation, GCP/GLP regulated sample testing, and reporting to support preclinical and clinical gene therapy program development.
• Independently develop, optimize, and troubleshoot ddPCR/RT-ddPCR related assays as well as other plate-based assays using variety of platforms including but not limited to Simple Western, colorimetric/luminescent/fluorescent ELISA, MSD, and enzyme activity assay in support of potency assay development for gene therapy programs.
• Prepare/scientific review of bioanalytical data and methods, protocols, and reports generated by internal and external laboratories.
• Participate and present in departmental and cross-functional project team meetings.
• Author and review relevant sections of regulatory submissions support the IND/CTA and BLA/MAA submissions.
• Manage CRO relationships for outsourced bioanalytical assay qualification/validation and sample testing.
• Stay current with the latest bioanalytical methods and technologies, current regulatory regulation and guidance, and industry's best practices.

Minimum Requirements

• Ph.D. in Biology, Biochemistry, molecular biology, Cell Biology, or a related field with minimum 5+ years of relevant experience and a strong publication record in peer reviewed journals or Master with 10+ years of directly related industry experience.
• Previous supervisory experience in bioanalysis assay designing, executing, and troubleshooting.
• Previous experience in managing bioanalysis assay outsourcing and CRO management.
• Deep understanding and extensive hands-on experience in ddPCR and RT-ddPCR assay development, troubleshooting, validation and sample testing in regulated lab for gene therapy support.
• Highly experienced in experiment designing, executing, and troubleshooting for ddPCR/Rt-ddPCR, ELISA, MSD, cell-based assay, FACS, or other novel platforms.
• Technical expertise in HPLC, LC-MS, LC-MS/MS, methodologies and instrumentation for protein analysis is desired.
• A strong self-starter and team player, independent strategic thinker, with a strong attention to details and excellent problem solving and complexity reduction skills.
• Ability to achieve objectives/timelines through collaborative efforts with coworkers, and managers.
• Excellent communication, interpersonal, organizational, and multi-tasking skills.

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 ....

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.