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 Research Associate II, Analytical Sciences, reporting to the Associate Director, Analytical Sciences, will be responsible for the development and execution of analytical methods used for routine testing of samples from process development, manufacturing, and preclinical groups. This individual will also participate in analytical test method development, qualification, and validation support along with analytical method tech transfer for future non-GMP and GMP drug product release. The location of this position is RTP (Durham), North Carolina.
Responsibilities
• Develop and execute molecular assays including digital PCR and quantitative PCR.
• Participates in testing to support method transfer, development, qualification, product characterization, routine GMP and non-GMP analysis, etc.
• Responsible for authoring and reviewing test methods, reports and developmental reports.
• Perform routine instrument maintenance and performance verification.
• Author timely reports detailing experimental work, SOPs and maintain clear, organized electronic and/or paper-based laboratory notebooks.
• Perform data analysis and effectively communicate results in formal reports and presentations for technical discussions and/or investigations with internal and external stakeholders, in accordance with good documentation practices (GDP).
• Maintain inventories and/or place orders of reagents and materials needed for the assigned projects allowing for timely execution of related lab work.
• Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.
• Writing of Standard Operating Procedures (SOPs) to support process development and analytical testing needs.
Minimum Requirements
• BS degree in Biology, Chemistry, or other relevant degree with 2+ years' experience, or MS with 1+ year(s) experience.
• Understanding of AAV-mediated gene therapy.
• Experience with digital PCR and quantitative PCR assays.
• Experience with industry requirements in GDP and GMP practices along with strong regulatory requirements knowledge.
• Excellent technical lab skills with attention to details and the ability to assume independent ownership of protocols/experiments.
• Experience and understanding of qualification and validation of analytical methods.
• Possess relevant knowledge and industrial experience in characterization and release testing to manufacture AAV gene therapy vectors or other complex biologics.
• Ability to multitask among multiple projects and teams, and work in a fast-paced, highly interactive environment.
• Strong ability to troubleshoot experiments.
• Self-motivated, organized, capable of working independe
Location: Durham, NC
Posted: Aug. 16, 2024, 8:14 a.m.
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