Head of T-Cell Product Characterization

Location
South San Francisco, CA, United States
Posted
Jun 13, 2021
Ref
5205032002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

Sana Biotechnology is looking to expand our team with a highly motivated and creative Head of T-Cell Product Characterization in the Analytical Development (AD) department to build and lead a function accountable for establishing deep characterization and knowledge of novel T-Cell based products. The position will also assume a key leadership role in the establishment of CMC control strategies for Sana's pipeline.

DUTIES AND RESPONSIBILITIES
  • Design characterization strategies to deliver impactful understanding of the T-Cell product biology, heterogeneity and function to identify and justify critical quality attributes (CQAs)
  • Act as a leader for cellular immunology and T-Cell product characterization to guide process and analytical development, process understanding and the establishing of phase-appropriate control strategies
  • Advance scientific understanding of T-Cell product CQAs and correlation to product efficacy and safety
  • Serve as Analytical Lead of cross-functional teams. In this role, the candidate is accountable for the establishment of science-driven, phase appropriate, and risk-based analytical development and control strategies to support T-Cell based programs from clinical development to commercial registration
  • Lead automation and data management strategies to accelerate product characterization, data processing and visualization
  • Partner with Research, Tech Sciences, Development Sciences and Clinical teams to advance T-Cell product characterization
  • Build and lead the Immunoassay Assay team to develop, qualify and manage lifecycle of methodologies to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA/applicable global health authority requirements and expectations
  • Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
  • Create an inspiring vision for the T-Cell Product Characterization/ Immunoassay function
  • Work with other Tech Ops stakeholders in PD/AD, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations.
  • Collaborate with internal and external stakeholders including health authorities and industry organizations to identify trends and expectations and incorporate them into Sana's CMC control strategies
  • Establish regular interface and build strong connections with CMOs and contract labs
  • Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
  • Communicate with facts, clarity, and authenticity up, down, and across organizations.
  • Attract and recruit top talent, celebrate diversity, motivate and empower, delegate effectively, and manage performance

QUALIFICATIONS

Basic Qualifications
  • Ph.D. in Immunology, Cell Biology, or other related disciplines and 10+ years of experience in adoptive T-Cell based therapies. BA and/or MS with equivalent combination of education and work experience are considered.
  • Significant prior experience in driving characterization of T-Cell therapy products to advance product understanding, process development and the establishment of control strategies
  • Creative problem solver with the ability to leverage technologies to dive deeper and more broadly in advancing our knowledge in the field of T-Cell biology and function to support product and process development
  • Significant prior experiences in advanced analytical platforms and related data analysis, e.g. immunoassays, multi-color flow cytometry and/or single cell analytical assays
  • Demonstrated track record of success in building, leading and empowering teams; excellent ability to work collaboratively in a complex, matrix, fast-paced environment; demonstrated talent to foster team productivity and cohesiveness, as well as the skills to drive innovation within the team.
  • Strong working knowledge and interpretation of FDA/EMA and ICH regulations and guidelines
  • Demonstrated technical proficiency, scientific creativity, collaboration with others, independent thought and learning agility
  • Strong verbal and written communication skills. Ability to communicate effectively with others internally and externally to the organization
  • Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
  • Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
  • Ability to effectively work through change and ambiguity
  • Ability to engage in crucial conversations - providing and receiving feedback
  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19.

Preferred Qualifications
  • Expertise in analytical methods to interrogating functional phenotype of T-Cell subsets, proliferation, exhaustion, cell health and metabolism, etc.
  • Experience with data and pathway enrichment/analysis, R script or similar functional tools, and visualization tools such as Spotfire
  • Understanding of cell metabolism and relationships of engineered T-cell therapeutics to in vivo function in the tumor microenvironment
  • Experience with testing support for GLP and GMP environments, quality documentation, technical troubleshooting as related to process development and manufacturing


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job description listed above is representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

The Company is committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short and long term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.