Director, Cell-based Assays

Director/Associate Director, Cell-based Assays

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  The candidate will assume a leadership role in developing, optimizing and qualifying  cell-based assays to support product characterization, in-process, release and stability testing of cell and gene therapy products.

What you’ll do

• Lead the Cell-based Assay team to develop, qualify and manage lifecycle of analytical methods to ensure product quality and compliance with applicable ICH guidelines and FDA/EMA/applicable global health authority requirements and expectations
• Lead science-driven and phase appropriate functional assay development and specification setting to support programs from proof of concept to commercial registration
• Serve as a subject matter expert and author and/or review relevant sections of CMC documentation in support of INDs, IMPDs and BLA submissions, amendments, and briefing documents
• Implement state-of-the-art cell-based assay technologies. Hire exceptional subject matter experts of those technologies
• Establish regular interface and build strong connections with Contract Manufacturing Organizations (CMO) and Contract Laboratories
• Collaborate cross-functionally on broader technical development strategy and leadership decisions
• Seek and analyze data from a variety of sources to support decisions and align others
• Work with other Tech Ops stakeholders in process and analytical development, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations.
• 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.
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• PhD. in a relevant scientific discipline such as Cell Biology, Biochemistry, or other relevant field, a BS or MS with appropriate experience may be considered
• 8+ years of relevant experience in developing and qualifying cell-based assays to support in-process, release and stability testing of cell and gene therapy products
• Demonstrated experience in leading AD teams and working in partnership with process development teams to deliver an appropriate Control Strategy of clinical and/or commercial products
• Strong working knowledge and interpretation of FDA/EU 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
• Excellent problem-solving skills as well as 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

What you should know

• 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 be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC

How we work together

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

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.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, employer paid basic life insurance,  additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

We are 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, social class (including caste/caste identity), 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.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.