Senior Scientist, Downstream Process Development

ShapeTX® is pioneering the field of programmable RNA medicines to repair the genetic causes of diseases. By merging innovations in AI and RNA technology to generate and analyze hundreds of billions of therapeutic possibilities, ShapeTX is developing breakthroughs in RNA editing, next-generation AAVs, and disruptive gene therapy manufacturing. The ShapeTX platform enables pharma innovators to design treatments across a wide range of diseases, including rare genetic disorders as well as debilitating conditions, such as Alzheimer’s, Parkinson’s, and many more. 

At Shape^TX, we are a dynamic team of professionals who are dedicated and passionate about making cures a reality. Through diversity of thought, scientific knowledge, professional rigor and focus we are merging cutting-edge science with extensive drug development expertise to unlock cures to many debilitating diseases.

Shape Therapeutics is headquartered in Seattle, Washington with a satellite site in Boston, Massachusetts.

ShapeTX is looking for a scientifically innovative individual and respected people manager to join the Process and Product Development team as Senior Scientist, Downstream Development. In this role, you will develop and implement viral vector purification strategy and processes for the production of ShapeTX’s novel gene therapy technology platform.

The Senior Scientist, Downstream Development will take primary responsibility for envisioning and executing the harvest, chromatography, and filtration development strategies and technologies to advance AAV purification as well as support clinical regulatory filings with an eye towards commercialization. This effort will be applied to develop a holistic process development platform to support the wide range of ShapeTX therapeutic opportunities. You will also be expected to exemplify and cultivate ShapeTX’s values and culture.

This is an exciting opportunity to join a high-growth startup and lead the product development strategy for a pioneering RNA targeting technology to create the next generation of gene therapies. The successful candidate will have an intellectual motivation to implement new technologies and novel strategies with direct application to human diseases. Creativity, scientific rigor and a thirst for excellence are essential.

ROLE RESPONSIBILITIES

Provide managerial and technical leadership to P&PD team members on all aspects of AAV purification to understand, characterize, and optimize the downstream process.

• The candidate will work as a member of the P&PD team to lead and perform downstream development to create highly purified rAAV viral vector
• The main responsibility for this role is successful development of downstream purification of rAAV from cell culture using state of the art viral vector manufacturing techniques such as affinity chromatography.
• She/he will be also responsible for working with the P&PD team to support small scale screening activities, lab scale material generation for development studies, and documenting downstream unit experiments and operation for technology transfer and/or regulatory filings.
• Pioneer cutting edge purification techniques and technologies to advance the understanding of our manufacturing drug process and drug product.
• Continue to hire and retain high performing staff to support the responsibilities of the Downstream Development group.
• Author and review technical development and regulatory documents
• Build and maintain effective working relationships with key internal and external stakeholders.
• Participate in ongoing downstream technology development initiatives, as well as generating new ideas and proposals for future projects
• As part of a growing development team, the candidate will be required to perform activities across the team in addition to purification experiments (i.e. cell line, bioreactor, and/or analytical development).

Requirements:

Preferred Qualifications:

• PhD in biochemistry, bioengineering or related field with 5-7 years of industry experience in downstream development. Excellent non-PhD candidates will also be considered.
• Demonstrated scientific rigor through patents or peer-reviewed publications in top tier journals
• Understanding of related disciplines (e.g. cell line development, upstream cell culture, regulatory, translational and pharmaceutical sciences).
• Demonstrated scientific productivity (publications, abstracts, etc.)
• Proven scientific writing skills and good communication skills
• Proven leadership skills in building and retaining high performing teams
• Capacity to adapt to a fast-paced and changing environment

Skills and Experience

• Proficiency with standard downstream techniques involved in creating platform harvest criteria, chromatography unit operation order, and strategy.
• Working knowledge of cell lysis procedures and viral vector recovery strategy throughout downstream processes
• Demonstrated experience in downstream process development
• Ability to collaborate and work effectively on cross functional teams, and rapidly adapt technologies and processes to meet project needs
• Strong technical writing skills to author reports and appropriate regulatory filing sections
• Critical thinking and clear verbal communication skills
• Experience with cell lysis and harvest procedures
• Experience with chromatography resin screening and selection
• Experience with high throughput tools, experimental design and analysis as pertains to downstream development
• Ability to lead, mentor and develop scientific talent at different levels
• Excellent communication and decision-making skills
• Familiarity with GMP requirements and experience with regulatory documents (IND, BLA, etc.)
• Familiarity with current viral vector manufacturing techniques a plus
• Familiarity with analytical tools to evaluate process yield and quality a plus

We aspire to Shape Life! not only through our science, but also through our commitment to foster an inclusive environment that supports diverse perspectives and experiences.