Scientist - Upstream Process Development

Location
Research Triangle Park, NC, United States
Posted
Sep 05, 2020
Ref
9618
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
About us:

AskBio was founded by gene therapy industry leaders, whose discoveries and AAV platform technology and applications form the foundation for how important gene therapies are effectively and safely delivered to millions of people who suffer from incurable conditions.

When you join the AskBio team as the Scientist - Upstream Process Development:
  • You'll be part of one of the most exciting gene therapy research and delivery companies in the world
  • Your work will contribute to the advancement of therapies and applications that are revolutionizing curable possibilities
  • You will have opportunities for significant growth with competitive pay and outstanding benefits
  • You will be a part of a collaborative culture that shares a genuine desire and belief to change the world

About the role:

The purpose of the Scientist - Upstream Process Development is to develop upstream (cell culture) processes for production of recombinant adeno-associated viral (rAAV) vector gene therapies. This individual will work with a team of associates and scientists on upstream process development, scale-up, optimization, characterization and transfer of projects while providing scientific expertise, guidance and development opportunities.

Responsibilities and Accountabilities
  • Demonstrates innovative design, development and execution of process development projects through literature review and scientific teamwork
  • Assess and interpret experimental data using DOE and other statistical techniques
  • Develops robust, scalable and transferable processes for upstream production of rAAV clinical gene therapy vectors
  • Serve as a Subject Matter Expert (SME) for the development of robust, high-performing upstream processes with emphasis on transferability to cGMP manufacturing and supports regulatory filings
  • Training new or current team members and delegating tasks appropriately
  • Provide input on the acquisition of capital equipment
  • Assist in the generation of project and cost proposals, timelines and work plans by applying scientific knowledge and project management experience
  • Writes study reports, process characterization reports, transfer documents and regulatory documents
  • Authors manuscripts and presents results at scientific meetings
  • Contributes to building a culture that embraces continuous learning and innovation while encouraging team members to expand their technical skills and deepen their gene therapy expertise

About you:
  • BS, MS or PhD (chemical engineering, bioengineering, biology, biochemistry, virology, or related field) with 7+ years' experience, 4+ years' experience or 1+ years' experience, in biologics process development of large molecule or cellular therapies
  • Knowledge and experience with media development, fed-batch, perfusion, etc. cell culture methodologies
  • Knowledge and working experience with cell culture process development in mammalian cells, process scale-up, bioreactor design and optimization, and transient transfection
  • Knowledge and experience with process characterization and tech transfer is essential
  • Knowledge and experience with ambr systems
  • Knowledge of viral gene therapy (AAV vectors preferred); background in protein and/or viral vector engineering
  • Understanding and knowledge of regulatory requirements for biologic products
  • 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
  • Responsible for maintaining up-to-date knowledge of regulatory requirements and quality standards related to area of development.
  • Ability to work both independently and in a fast-paced team-oriented setting
  • Excellent written and verbal communication, work planning, data analysis and record keeping skills (with strong attention to detail) will be required

More about you:
  • Hands-on knowledge of DOE, JMP, FlowJo and GraphPad statistical software for use in design of technology development studies is highly desirable.
  • Experience in regulatory IND filing and working knowledge of US/EU CLD requirements is highly desirable.
  • Must be able to physically travel to remote locations, including, but not limited to, international and remote locations.
  • Must have a passport and ability to travel internationally.
  • Must be able to tolerate normal office climatic conditions associated with daily activities and in travel to remote locations.