Senior Director of Gene Delivery/Editing CMC Development

At Syncopation Life Sciences, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.

Syncopation is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner out of Stanford to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, Syncopation has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Join us to help make a difference.

Position Summary

Syncopation is hiring a Senior Director of Gene Delivery/Editing CMC Development function within the CMC/Technical Operations Organization.  This is a key role responsible for establishing the Gene Delivery and Editing technical development function.  The role will initially focus on lentiviral manufacturing process development, tech transfer to a CDMO in preparation for a registration enabling clinical trial for Syncopation’s lead cell therapy program.  The scope of the role covers the technical development responsibilities for gene delivery and editing in support of Syncopation’s entire cell therapy portfolio with the subsequent programs rapidly advancing from pre-clinical to clinical stages.  The successful candidate will partner closely with Syncopation’s discovery and translational research teams to select and design the gene delivery tools and develop process and control system to advance these candidates from research to clinical and eventually translate to commercial manufacturing processes.

What You’ll Do at Syncopation

The responsibilities of the Sr. Director of Gene Delivery/Editing will broadly include the below elements.

  • Guide the development, characterization and implementation of the gene editing and delivery process (internally as well as in partnership with CDMOs). As such, establish the long-term vision for the Gene Delivery and Editing CMC function
  • Establish a strong technical team responsible for developing manufacturing process for the selected gene delivery platform, which will be focused on lentiviral platform initially.
  • Select and develop analytical methods, internally and at contract labs, for the characterization of the vector as well as transduced drug product
  • Develop cost-effective gene delivery manufacturing process suitable for autologous and allogenic cell therapy programs
  • Author, review and approve technical documents that include IND enabling source documents and regulatory submissions.
  • Collaborate across all CMC functions including Process Science, Analytical Development and QC, Quality, Manufacturing and Regulatory
  • Design and build out a gene delivery lab to aid small scale development and generate technical work packages in support of IND submissions as well as to troubleshoot viral vector manufacturing issues.
  • Tech transfer viral vector (and other gene delivery platforms in the future) manufacturing process to CDMOs or from CDMO back for internal manufacturing, if needed.
  • Provide technical oversight to the gene delivery CDMOs and strategic oversight of the gene delivery topics within the cross functional CMC teams.
  • Interface with external consultants supporting Syncopation on the gene delivery related strategy topics.

Experience and Qualifications

  • Ph.D. or M.S. in Chemical or Biological Engineering, Molecular Biology, Genetics, Virology, or related disciplines with 10 plus years of relevant experience, with at least 3 years of experience directly in cell and gene therapy field.  Minimum 3 tears of experience leading scientists/engineers.
  • Experience developing viral vector manufacturing process, and evolving processes form research to clinical manufacturing and commercialization with broad life cycle management experience.
  • Experience in process and control system development, authoring technical sections of the IND, BLA and other regulatory submissions.
  • Experience tech transferring processes and methods to CDMOs/CMOs and internal manufacturing sites.
  • Demonstrated technical and people leadership,ability to influence without direct authority.
  • Strong problem solving, scientific reasoning skills including practical experience in implementing meaningful technology solutions to simplify cell therapy manufacturing.
  • Ability to effectively communicate complex technical content to a range of audience in oral and written formats.
  • Demonstrated evidence for problem solving, logical scientific reasoning, practical approach to implementing technology solutions to ultimately establish a reliable and robust manufacturing and supply network.
  • Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy.
  • Ability and willingness to roll up the sleeves and be hands-on and flexible while we are building the team.
  • Experience in working with cross functional product teams.
  • Proven record of being able to hire top technical talent.

EEO & Employment Eligibility

Syncopation Life Sciences, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Syncopation Life Sciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

Syncopation Life Sciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Syncopation, and it applies regardless of whether the position is located at a Syncopation site or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.