Research Associate Iii, Analytical Sciences

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:

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

Our values:

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.
• 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.
• 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.

The Research Associate III, Analytical Sciences, will be responsible for the development and executing cell-based potency assays to support In-process analytics, Process Development, non-clinical and GMP recombinant Adeno-associated virus (rAAV) vector manufacturing. 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 ideal candidate will have direct experience with the culture of various primary and immortalized mammalian cell lines, with an emphasis on cell line development and the use of those cells in analytical assays. The candidate should have a clear understanding of AAV-mediated gene therapy; however, prior experience in this field is not required. Experience in relative potency assays and GxP regulation is preferred but not required. The location of this position is RTP (Durham), North Carolina.
Responsibilities

• Author timely reports detailing experimental work, SOPs and maintain clear, organized electronic and/or paper-based laboratory notebooks.
• Responsible for authoring and reviewing test methods, reports and developmental reports.
• Writing of Standard Operating Procedures (SOPs) to support process development and analytical testing needs.
• Perform data analysis and effectively communicate results in formal reports and presentations for technical discussions and/or investigations with internal and external stakeholders.
• Apply molecular and cell-based assays including, but not limited to, AAV transduction, transfection, gene expression analysis, primer probe set design/validation, flow cytometry, in-vitro fluorescence immunocytochemistry and ELISA.
• Ensure lab areas are clean, organized and equipment, supplies and raw materials are available for use.
• Perform routine instrument maintenance and performance verification.
• Maintain inventories and/or place orders of reagents and materials needed for the assigned projects allowing for timely execution of related lab work.
• Participates in testing to support method transfer, development, qualification, product characterization, routine GMP and non-GMP analysis, etc.
• Cell-culture, differentiation, and adaptation of various mammalian primary and immortalized cell culture systems using aseptic techniques, with an emphasis on propagation, expansion, cryopreservation, and characterization.

Preferred Experience And Skills

• Excellent verbal and written communication skills with the ability to maintain formal recording.
• Extensive hands-on experience in mammalian cell culture methods and procedures including propagating cell lines as well as cell line characterization and cell differentiating, transfection/transduction and troubleshooting of cell viability by testing various parameters.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to multitask among multiple projects and teams, and work in a fast-paced, highly interactive environment.
• Strong ability to troubleshoot experiments.
• The ideal candidate will have relevant knowledge and industrial experience in characterization and release testing to manufacture AAV gene therapy vectors or other complex biologics.
• The ideal candidate will have experience and understanding of qualification and validation of analytical methods.
• Understands GDP and GMP regulatory requirements.
• Ability to innovate and use good judgment to achieve a solution.
• Self-motivated, organized, capable of working independently and in a collaborative environment with cross-disciplinary teams.
• Possess knowledge of, and experience with, in vitro-based cellular assays such as: In-Cell ELISA, Flow Cytometry, Capillary Western, TCID50, ELISA, ddPCR/RT-ddPCR, and immunofluorescent staining.
• Excellent technical lab skills with attention to details and the ability to assume independent ownership of protocols/experiments.
• BS degree in Molecular or Cellular Biology, Biochemistry or other relevant degree with 4-6 years research experience, or MS with 3-4 years’ experience (The level of this position will be based on the final candidate’s qualifications)

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 [email protected].
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.