Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain. 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 Overview The QC Stability Coordinator, reporting to the Sr. Director of QC, will be responsible for developing, designing, and maintaining the stability program of all AskBio Gene Therapy products. This role will ensure that the stability program for AskBio products meets the expectations of all regulatory agencies and remains compliant with all published requirements. The QC stability coordinator acts as an SME (Subject Matter Expert) and as such are expected to help with troubleshooting work with internal and external customers as the need arises. Responsibilities Oversee the stability program across all AskBio Gene Therapy products, including final drug products as well as key process inputs (i.e. drug substance, cell banks, etc.). Act as Subject Matter Expert (SME) supporting audits, both internal and external. Author, review, and approve stability protocols and reports Collaborate with third party laboratories that perform stability testing for AskBio Track, trend, and evaluate stability data to determine any adverse trends Write/Review Standard Operating Procedures for stability and other related topics Contribute to the regulatory filing process so that all stability data and relevant information is including and complete to support product applications Lead/participate in investigations related to stability data and testing Utilize the change control system to implement changes/improvements including owning, reviewing, assigning actions, and impact assessments. Work closely with Analytical Development, Quality Control, Quality Assurance, Production and any other relevant departments. Support other Analytical Development and quality control initiatives as needed, including but not limited to streamlining documentation, creating/updating SOPs, stability program, etc. Required Education and Experience Bachelor’s degree in a scientific field is required. Master’s degree is preferred. 8 years’ experience of Quality Control laboratory within the pharmaceutical or biotech industry Experience in the pharmaceutical industry working to cGMP requirements Preferred Experience and Skills Ability to handle multiple projects/teams simultaneously. Experience involving management of a GMP stability program 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 team. Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams. Asklepios BioPharmaceutical, 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. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.