Director of Analytical Chemistry

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Director of Analytical Chemistry, you will report to the Executive Director of Product Characterization and Analytical Chemistry to build the analytical chemistry function responsible for supporting the development of novel gene therapy products. The position will also play an important scientific leadership role in the establishment of CMC control strategies for Sana's pipeline. The title will be in line with experience.

What you'll do

• As the leader, design and implement the bioanalytical chemistry methods and characterization strategies to deliver impactful understanding of the critical reagents, viral vector physicochemical properties, heterogeneity, and function to identify and justify critical quality attributes (CQAs)
• Advanced knowledge and hands-on experience for bioanalytical chemistry such as HPLC, CE or LC-MS or ELISA, MSD and ddPCR based techniques to guide process and analytical development, process understanding
• Partnering with process teams to develop the residual clearance strategies for cell and gene therapies products and support the process related residuals methods development
• Advance scientific understanding of critical reagents, viral vector and cellular drug product CQAs and correlation to product efficacy and safety
• Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
• Contribute to build an inspiring vision for the analytical chemistry team
• Work with other Tech Ops stakeholders in PD/ADQC, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations.
• Establish regular interface and build strong connections with CMOs and contract labs

What we're looking for

• Ph.D. in Bio-Analytical Chemistry, Virology, Molecular Biology, or other related disciplines and 8+ years of experience in cell and gene therapy products. BA and/or MS with equivalent combination of education and work experience are considered.
• Significant experience in developing analytical chemistry-based methods for characterization of critical reagents, viral vectors, cellular drug products and process related residuals to advance product understanding, process development and the establishment of control strategies
• Problem solver with the ability to leverage novel analytical technologies to dive deeper and more broadly in advancing our knowledge of physicochemical and biological properties to support product and process development
• Experience with critical reagents, raw materials physicochemical properties, functional assays and purity/impurities assays
• Working knowledge and interpretation of FDA/EMA and ICH regulations and guidelines
• Demonstrated technical proficiency, scientific creativity, collaboration with others
• Strong verbal and written communication skills. Ability to communicate effectively with others internally and externally to the organization

What will separate you from the crowd

• Significant experience of analytical chemistry for critical reagents, cellular and vector products and related impurities
• Passion for science and the drive for positively impact on patient’s life
• Strive for scientific excellence and focus on delivering results
  

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.