Process Development Scientist/Sr. Scientist

About the job

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 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 Process Development Scientist/Sr. Scientist skilled in cell therapy process development. The PD Scientist/Sr. Scientist will lead development studies in support of a pivotal ready process, including process optimization/characterization. We are seeking a highly motivated individual who possesses a technical understanding of process development for cell therapy products and can manage multiple development activities simultaneously.

The successful candidate will work closely with the Process Sciences team and the broader CMC team to support development of GMP processes for manufacture of Syncopation’s cell therapy products. The individual will also collaborate cross-functionally to ensure timely development and manufacture of drug products as well as support regulatory submissions. The role is based in San Mateo, CA.

Two positions are available for this role.

What You’ll Do at Syncopation

  • Lead planning, execution, analysis, and communication of data related to development studies supporting GMP process development for T cell therapy products
  • Support process transfer to external manufacturing partners
  • Support process characterization and comparability studies, enabling development of a pivotal-ready manufacturing process
  • Participate in internal laboratory set up, equipment procurement, and establish internal process development practices
  • Author relevant documentation (protocols, batch records, technical development reports)
  • Effectively communicate data to internal stakeholders and external partners
  • Interface and work collaboratively with external manufacturing partners
  • Proactively enable cross-functional collaborations with internal stakeholders, external partners, and consultants.
  • Evaluate emerging technologies and platforms for application in product pipeline development

The Right Stuff

Preferred Qualifications:

  • PhD, Master’s with 5 plus years, or B.S./M.S. with 7 plus years of industry experience. Degree in a relevant scientific area such as biotechnology, bioprocess, molecular biology, immunology, biochemistry (required)
  • Experience in working with multidisciplinary teams. Experience working in a small biotech/start up environment is a plus.
  • At least 2-3 years of prior experience in clinical scale immune cell isolation, T cell culture, and/or mammalian cell culture
  • At least 2-3 years of prior experience in cell therapy and/or process development
  • Expertise in flow cytometry analyses, functional assays (cytotoxicity, cytokine release, proliferation) a plus
  • Experience with GMP requirements and interfacing with external collaborators, outsourced manufacturing highly desired.
  • Experience in process characterization, identification of critical process parameters, critical quality attributes highly desired.
  • Independently motivated, excel at driving execution, detail oriented, creative approach to problem solving, and adept at working in a fast-paced environment
  • Must have interpersonal, organizational, written, and verbal communication skills, and the ability to work collaboratively in a team environment
  • Proficiency in Office, Design of Experiments, JMP, and other productivity and data analysis tools is a plus
  • Experience in writing authoring source content for regulatory submissions is a plus.

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.