Associate Director/Director of MSAT

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 Manager/Sr Manager of MSAT within the Technical Operations Manufacturing Organization.  This is a key role within the Syncopation Manufacturing Organization focused initially on technical support of external manufacturing partners for both cell processing and gene delivery platform and in time on internal manufacturing operations. Our current network involves up to 7 CDMO partners and it is expected to grow as we build out the end-to-end supply chain for our cell therapy portfolio, with the lead asset already in clinical stage off the development. Work at the CDMO includes development of process and analytical methods, tech transfer in to the CDMOs (and potentially back to Syncopation or another CDMO in the future) in preparation for a registration enabling clinical trial for the lead asset. The candidate will work closely with other functions in the Technical Operations team (Process Sciences, Gene Delivery and Editing, Future Quality and CMC Regulatory) to develop the internal and external manufacturing strategy and execute against the strategy to ensure reliable deliverables throughout the project life cycle.   This role is critical in developing a strong partnership with our CDMOs in pursuit of advancing our pipeline. The MSAT role is expected to be hands-on in the technical and operational details of the manufacturing process with focus on short term execution on aggressive timelines but at the same time on innovating the long term manufacturing strategies.  The role is based in San Mateo, CA but may also be suitable for a hybrid arrangement.

What You’ll Do at Syncopation

The responsibilities of the Manager/Sr Manager of MSAT will broadly include the below elements.

  • Review capabilities of the CDMOs against Syncopation’s product and technology requirements and develop a tech transfer plan
  • Translate process and analytical technical requirements into executable and compliant manufacturing and quality documents.
  • Initiate and lead the technology transfer teams for process and analytical method transfers to the CDMO and in the future out from the CDMO to potential third-party partners or Syncopation. 
  • Develop manufacturing control strategy for the Syncopation product and author appropriate sections of the regulatory documents describing the control strategy
  • Review quality and manufacturing procedures at the CDMO and ensure they meet the requirements of Syncopation process and control systems.
  • Participate in CDMO and supplier audits, identify technical gaps and develop mitigations. Develop a clear set of technical material requirements.
  • Oversee implementation of process and analytical changes throughout the product life cycle
  • Identify and implement appropriate automation solutions to simplify and evolve the cell therapy manufacturing platform for the current and future products
  • Participate as a subject matter expert in health authority interactions, including authoring of regulatory documents

Experience and Qualifications

  • Undergraduate/Graduate degree in Chemical or Biological Engineering or life sciences with 5-10 years of relevant experience in the biotech industry.  Experience working with viral vector and cell therapy processes is highly desirable. Direct or indirect supervisory experience leading small teams is preferred.
  • Tech transfer experience in both early stage (clinical manufacturing) and late stage (commercial enabling) to external partners is required.
  • Experience working external CDMO relationships as well as working in internal manufacturing operation is highly desirable
  • Demonstrated evidence of strong project management and timely execution
  • Ability to effectively lead complex projects with a cross-functional internal/external team.
  • Ability to troubleshoot complex manufacturing investigations combining technical, compliance and business considerations working with a cross functional teams
  • Strong technical foundation in biologics or cell/gene therapy manufacturing process and technology
  • Ability to effectively communicate complex technical content to a range of audience in oral and written formats.
  • Ability to focus on short term delivery and at the same time directional focus on the long-term partnership and strategy
  • 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.
  • Ability to hire, develop and retain strong technical talent.
  • This role may require travel up to 25-35% of the time

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.