Principal Research Associate, Immunoassay Method Development

About the role

Sana Biotechnology has an exciting opportunity for a talented and highly motivated Principal Research Associate (PRA) to join the Molecular Biology team focusing on the characterization and/or release assay development for drug substance (LVV) and drug product for T cell therapies. The ideal candidate will have knowledge of immunoassay method development for lentiviral vectors and T cell-based products to advance Sana's novel cell therapy programs. You will develop methods for the characterization of novel viral vectors, gene editing reagents, cell therapy drug products and process related impurities. You will report to Scientist within Molecular Biology group. This role provides the opportunity to work closely with Technical Operations colleagues with the goal of developing robust biomanufacturing processes and contributing to the deeper understanding of our products and their impurity profiles. You will demonstrate innovation and resourcefulness by leveraging internal capabilities and external collaborations to bring cutting edge technologies to Sana.

What you'll do

• With minimal supervision, develop robust analytical methods for characterizing intermediates, drug substances/products and measuring residual impurities including proteins, nucleic acids, viral vectors, cell therapy products and small molecules

• Draft technical documents (e.g., Test Methods, SOPs, Development Reports, Technical Reports, and business enabling documents) and comprehensive study plans

• Maintain accurate documentation of experiments in ELN and reports

• Work closely with Analytical Operations and QC during knowledge transfer, method transfer and co-qualification activities

• Maintain, calibrate, and operate analytical equipment and instruments

• Ensure that departmental areas are maintained per established guidelines

• Initiate and lead efforts to bring new analytical technologies on site through utilization of internal resources/expertise and collaboration with external vendors

• Represent Molecular Biology team on external and internal project teams

• Serve as a subject matter expert for one or more analytical techniques

• Overcome obstacles (time constraints, material limitations and instrumental capabilities) through creative solutions, collaboration and problem solving

What we're looking for

• MA/MS/MBA with 4+ years of relevant experience; or

• BA/BS with 6+ years of relevant experience

• Experience in analytical method development and qualification of plate-based immunoassays and impurities assays (ELISA, MSD, Luminex)

• Background in immunology, molecular biology, cell biology

• Knowledge of T cell biology and immune cell therapy (e.g., viral vectors, CAR T functional assays) is strongly desired

• Demonstrated ability to design, execute, and analyze complex experiments with statistical analysis and scientific rigor

• Familiarity with flow cytometry and PCR based methods

• Excellent skills in Microsoft Office, Smartsheet, data analysis software (e.g. JMP, Geneious, Snapgene, SoftMax Pro), and other applications

• Ability to think critically and demonstrate troubleshooting and problem-solving skills

• Overall understanding of drug development process and its impact on projects, goal and timelines is preferred

• Understanding of ICH guidelines (Q2R2, Q14) and GxP is highly desired

• Excellent verbal and written communicate skills for technical and non-technical audiences

• Detail oriented, self-motivated, independent, adaptable, and able to prioritize and manage several projects concurrently

• Demonstrated ability to work independently and in cross-functional teams

What will separate you from the crowd

• Working independently on projects with minimal supervision

• Immunoassay method development experience at a cell and gene therapy company

• Experience with method validation and transfer to QC

• Familiarity with FDA and ICH guidelines and GxP principles

• Experience with multi-attribute method development (for e.g., Luminex, MSD) is highly desired.

• Contributed to regulatory filings by authoring sections and generating data and source documents

• Experience working with CDMOs and contract testing labs

• Demonstrated leadership for effective project management and supervisory aptitude / experience to enable potential expansion of responsibility to include direct reports

• Demonstrate to work independently and as a part of a team

• Demonstrate effective interpersonal and communication skills

• Demonstrate core values like teamwork, integrity, accountability, and excellence

What you should know

• This is a lab-based onsite position at South San Francisco office

• The base pay range for this position at commencement of employment is expected to be between $110,000 and $130,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together for patients

• 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 (various paid time off benefits, such as holidays, vacation, sick time, and 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. For more details on our benefits, visit Sana's Benefits Portal.

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.