Research Associate II Pre-Clinical Vector Manufacturing

Asklepios BioPharmaceutical Inc. (AskBio) is a leading clinicalstage gene therapy company founded in 2001 based on the work of adenoassociated virus (AAV) gene therapy visionary and pioneer Jude Samulski PhD. Since that time our commitment to developing lifesaving medicines that can potentially cure genetic diseases has never wavered.

At AskBio weve 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 Parkinsons disease and congestive heart failure. Our gene therapy platform includes Pro10 an industryleading proprietary cell line manufacturing process and an extensive AAV capsid and promoter library.

We became a whollyowned 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 peoples 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 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 whats right in every situation. Make clear commitments and follow through.

The Research Associate II PreClinical Vector Manufacturing reporting into Scientist II& Team Lead position is to manufacture for research and GLP grade recombinant Adenoassociated virus (rAAV) vectors as part of AskBios Vector Core. The rAAV vectors manufactured will support capsid technology development intellectual property portfolio and progression of internal and external earlystage gene therapy programs. This position requires of small and pilotscale 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 earlystage 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 laboratoryfocused role
• Knowledge and experience with upstream or downstream process operations such as cell culture centrifugation depth filtration tangentialflow filtration and/or chromatography with expertise in at least one functional area is required.
• Strong organizational analytical and problemsolving skills
• Demonstrated ability to present ideas information and data effectively via oneonone 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 fastpaced highly interactive environment
• Selfmotivated 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 laboratoryfocused 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 ViCELL BLU (cell counter) ViCELL 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 rootcause 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 jobrelated 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 ator sending us an email at .

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.