Senior Scientist – Upstream Process Development Group Leader

The Sr. Scientist, Upstream Process Development Group Leader, will lead the developing upstream (cell culture) processes for recombinant adeno-associated viral (rAAV) vector gene therapies. This position manages and mentors 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
  • Assesses and interprets experimental data using DOE and statistical techniques
  • Develops robust, scalable, 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 support regulatory filings
  • Leads both from the bench and from the desk (designing studies, analyzing data, preparing reports and documents)
  • 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
  • Builds 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: 

  • PhD (chemical engineering, bioengineering, biology, biochemistry, virology, or related field) with 5+ years’ experience or MS with 8+ years’ experience in process development of large molecule or cellular therapies
  • Knowledge and experience with media development, fed-batch, perfusion, etc., methodologies
  • Knowledge and working experience with cell culture process development in mammalian cells, process scale-up, bioreactor design and optimization, and transfection
  • Knowledge and experience with process characterization and transfer is essential. Expertise in DOE and statistical analysis of data is essential
  • Knowledge and experience with ambr systems
  • Knowledge of viral gene therapy (AAV vectors preferred); background in protein and/or viral engineering
  • Experience leading teams of scientists and associate scientists
  • 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
  • Hands-on knowledge of DOE, JMP, FlowJo and GraphPad statistical software for use in design of technology development studies is highly desired
  • Experience in regulatory IND filing and working knowledge of US/EU CLD requirements is highly desired