Research Associate II, Pre-Clinical Vector Manufacturing

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.

The Research Associate II, Pre-Clinical Vector Manufacturing, reporting into Scientist II& Team Lead, position is to manufacture for research and GLP grade recombinant Adeno-associated virus (rAAV) vectors as part of AskBio’s Vector Core.  The rAAV vectors manufactured will support capsid technology development, intellectual property portfolio and progression of internal and external early-stage gene therapy programs.  This position requires execution of small and pilot-scale manufacturing campaigns with the ability to evaluate and report the results to colleagues.

Job Responsibilities

• Responsible for rAAV vector manufacturing for research and GLP grade studies to support rAAV technology improvements and progression of early-stage gene therapy programs.
• Manufacture rAAV vectors by independently executing upstream and downstream process activities such as cell maintenance, production in shake flasks, WAVE bioreactors, and stir tank bioreactors, and purification by filtration and chromatography technologies.
• Evaluate and summarize manufacturing data and close out batch documentation.  As needed, assist with analysis of the manufacturing data and prepare and present updates to internal customers, teams, and management.
• Support process investigations, improvements, and optimization activities and engage, as needed, with senior research associates and subject matter experts to ensure successful resolution or implementation.
• Advise on opportunities for process improvement and independently develop and execute development protocols.
• Support process development activities, including technology transfer and training, from internal and external subject matter experts
• Support the preparation of manufacturing reports and make oral presentations to other scientists and management

Minimum Requirements

• Bachelors degree in a biological or engineering discipline required (Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or equivalent)with 2 years of relevant experience in laboratory research, biologics manufacturing; or MS degree in a biological or engineering discipline required (Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or equivalent)
• Desire to continue in a laboratory-focused role
• Knowledge and experience with upstream or downstream process operations, such as cell culture, centrifugation, depth filtration, tangential-flow filtration, and/or chromatography with expertise in at least one functional area is required.
• Strong organizational, analytical, and problem-solving skills
• Demonstrated ability to present ideas, information, and data effectively via one-on-one discussions, team meetings and collaborative interactions
• Demonstrated ability to independently generate results and innovative solutions.
• Excellent written and verbal communication, work planning, data analysis and record keeping skills with strong attention to detail is required

• Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment
• Self-motivated, organized, capable of working independently as well as in a collaborative/team environment

Preferred Skills & Experience:

• Relevant experience in lab laboratory research, biologics manufacturing and a desire to continue in a laboratory-focused role
• Experience in bioprocess manufacturing, preferably in rAAV and/or recombinant protein/biomolecule bioprocess manufacturing
• Hands on experience with 10L and/or 50L stirred bioreactors with single use bags (SUB) and use of Delta V or similar software
• Hands on experience with aseptic mammalian cell culture, seed trains, plus Vi-CELL BLU (cell counter), Vi-CELL Metaflex or Cedex (pH and metabolic measurements) or similar instruments
• Understanding of standard settings for bioreactor recipes/programs including temperature, pH, DO, agitation, and gas mixes
• Knowledge of and/or experience with perfusion/ATF system bioreactor operations
• Experience with cGMP and following good documentation practices is a plus.
• Familiarity with root-cause analysis techniques and risk management approaches.
• Understanding of design of experiments and familiarity with statistical software, such as JMP or equivalent
• Experience with data aggregation, analysis, and reporting is a plus.
• Familiarity with electronic notebook or manufacturing systems is a plus.

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.