Quality Control Analyst II

Ask Bio 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.

Ask Bio’s gene therapy platform includes Pro
10™, 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.

Pioneering science to create transformative molecular medicines.

Lead innovative science and drive clinical outcomes to transform people's lives.

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

• 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.

Will be responsible for performing routine testing on analytical methods in the GMP Quality Control laboratories and supporting quality events.

This position is based on site in Durham, NC and reports to the Associate Director, Quality Control.

• Perform routine analytical testing including but not limited to cell‑based potency assays, ddPCR, qPCR, ELISAs, limit tests using HPLC techniques.
• Prepare laboratory solutions, maintain cell lines, maintain inventory of materials, and other day‑to‑day laboratory activities.
• Participate in tracking and trending activities for analytical data.
• Maintain laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner.
• Support activities for qualification of laboratory equipment and analytical methods.
• Serve as a trainer for applicable methods for new analysts.
• Support Quality Control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, etc.
• Work closely with Analytical Development, Quality Control, Quality Assurance, Production and any other relevant departments.
• Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
• Participate in continuous improvement projects in the AD and QC labs.
• Revise processes, work instructions, SOPs, forms, protocols, and reports.
• Own deviations, CAPAs, change controls, and OOS investigations driving them to closure in accordance with internal timelines and external partners.

• Bachelor’s degree in a scientific field
• 2+ years of experience in cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field
• Ability to handle multiple projects/teams simultaneously
• Ability to work independently in a fast‑paced, highly interactive environment with minimal supervision
• Excellent verbal and written communication skills
• Ability to build open and collaborative relationships and work effectively as a member of a multi‑disciplinary…