Intern- Computer System Validation

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, Germany, 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 Summary

The Computer System Validation Intern will work collaboratively with the Computer System Validation (CSV) team to achieve key group and company objectives. This position will provide research, validation, and due diligence support to the CSV and cross-functional teams.

This position is based in RTP, North Carolina and will report to the Associate Director, Computer System Validation.

Job Responsibilities

• Support the development and execution of test scripts and validation lifecycle documentation for laboratory instruments

• Conduct research to assist in the development of user requirements and to facilitate validated system release to end users

• Provide due diligence support for, and assisting in creation of, update presentations and project charters for consumption by senior leadership and steering committees

• Build collaborative and meaningful connections with broader AskBio team (including Quality Assurance, Facilities Engineering, Translational Medicine, Analytical Development, etc.) through demonstrated commitment to excellence

• Develop additional best practices for data integrity and aligning with quality assurance initiatives for AskBio’s validation program

• Communicate with stakeholders regarding project status, risks, and proposed mitigations

Minimum Requirements

• Must be pursuing at least a Bachelor’s degree in Pharmaceutical Science, Biomedical Science or other STEM related field

• Must be at least a sophomore in university at the time of your application

• Previous experience in a work setting or prior internship

• Ability to communicate verbally and in writing effectively

Preferred Education, Experience and Skills

• Proficient with MS Office Suite and ability to learn new technologies quickly

• Excellent verbal and written communication skills

• Available to work full-time during the summer months (May-August)

• Familiarity with computerized laboratory systems / instruments

• Excellent organizational skills and attention to detail

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.