Research Associate II, Analytical Support na AskBio

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 Research Associate II, Analytical Sciences, reporting to an Associate Director or Scientist in Analytical Sciences, will be responsible for the development and execution of 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 immortalized mammalian cell lines, with preferred experience in executing cell-based potency assays. The candidate should have a clear background in cellular and molecular biology. Knowledge and previous experience with AAV-mediated gene therapy would be beneficial but is not required. Experience with GxP regulation is preferred but not required. The location of this position is RTP (Durham), North Carolina.  

Job Responsibilities

• Cell-culture, differentiation, and adaptation of various mammalian immortalized cell culture systems using aseptic techniques, with an emphasis on propagation, expansion, cryopreservation, and characterization

• 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

• 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, developmental reports, SOPs, and COAs/COTs

• Perform routine instrument maintenance and performance verification

• Maintain organized electronic and/or paper-based laboratory notebooks 

• Perform data analysis and effectively communicate results in formal reports and presentations for technical discussions

• 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

Minimum Requirements

• Master’s degree in biology, chemistry or related field OR Bachelor’s degree in biology, chemistry, or related field with 2+ years’ relevant work experience OR High School Diploma and 6+ years’ relevant work experience

• Extensive hands-on experience in mammalian cell culture methods of various cell lines including cryopreservation, transfection/transduction, and troubleshooting

• Possess knowledge of, and experience with, in vitro-based cellular assays such as: ELISA, Flow Cytometry, MSD, 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 

• Understands GDP and GMP regulatory requirements

• 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 independently and in a collaborative environment

• Excellent verbal and written communication skills with the ability to maintain formal recording. 

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)  

• Ability to innovate and use good judgment to achieve a solution

Preferred Education, Experience and Skills

• Experience and understanding of qualification and validation of analytical methods

• Knowledge of data analysis software such as Gen5 and Softmax Pro

• Excellent communication skills with ability to collaborate with colleagues across multiple platforms including e-mail, Microsoft Teams, and Sharepoint sites

• Relevant knowledge and industrial experience in characterization and release testing to manufacture AAV gene therapy vectors or other complex biologics

AskBio 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.