Intern- Pre-Clinical Manufacturing, Strategic and Technical Services

Asklepios BioPharmaceutical, Inc. (AskBio)Durham, NC
34dOnsite

About The Position

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 Intern, Pre-Clinical Manufacturing, Strategic and Technical Services reporting to the Strategic Technical Services Senior Associate of Pre-Clinical Manufacturing will assist with strategic and technical services (STS) activities which support for the manufacture of research and GLP-grade recombinant Adeno-associated virus (rAAV) vectors as part of AskBio’s Pre-Clinical Manufacturing (PCM). The rAAV vectors manufactured will support capsid technology development, intellectual property portfolio and progression of internal and external early-stage gene therapy programs. The Strategic and Technical Services Intern will work closely with individuals responsible for screening and fit-to-platform activities for new and novel rAAV vectors in pre-clinical manufacturing. The position will support in designing and executing studies, investigations, managing process data, and ultimately developing technical expertise to ensure continuity in pre-clinical manufacturing. This opportunity will be based in our Research Triangle Park (RTP), North Carolina headquarters.

Requirements

  • Currently pursuing a Bachelor’s degree in Biomanufacturing, Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, Biochemistry, or equivalent
  • Must be at least a Junior in college at the time of your application
  • Proficient with MS Office Suite and ability to learn new technologies quickly
  • Excellent verbal and written communication skills
  • Proactive, takes initiative, and solution-driven mindset
  • Strong sense of accountability and ability to prioritize multiple tasks
  • Excellent organizational skills and attention to detail
  • Flexible and willing to support a variety of tasks for the STS team
  • Able to work full-time hours during the summer (May-August) at an AskBio office

Nice To Haves

  • Currently pursuing a Master’s degree in Biomanufacturing, Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, Biochemistry, or equivalent
  • Prior internship, work, or volunteer/extracurricular experience

Responsibilities

  • Support screening, feasibility, and fit-for-platform studies for new and novel rAAV vectors to support rAAV technology improvements and progression of early-stage gene therapy programs
  • Assist with STS documentation including investigations, protocols, reports, process descriptions, risk assessments, and SOPs
  • Support investigations and root cause analysis, coordinating with appropriate teams to implement corrective actions to prevent recurrence, and meet program goals and delivery timelines
  • Participate in the development of Electronic Lab Notebook systems for STS utilization and pre-clinical manufacturing utilization
  • Learn and implement process improvement initiatives for the pre-clinical manufacturing team
  • Provide updates on the status of process improvement initiatives, investigations, and process performance to leadership
  • Evaluate new technologies and process operations in collaboration with process development and manufacturing sciences and technology to identify opportunities to improve processes and workflow for the pre-clinical manufacturing team.
  • Work closely with analytical team to collect, summarize and evaluate manufacturing data and close out batch documentation
  • Support process development activities, technology transfer and training, internal and external manufacturing, and analytical development activities
  • Support the preparation of technical reports and make oral presentations to scientists and management
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