Scientist, Analytical Tech Transfer
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. As a Scientist, Analytical Tech Transfer Person in Plant (PiP), you will report to Director, Flow Cytometry to oversee day-to-day analytical activities at Sana’s key contract development and manufacturing organization (CDMO). This will include coordinating with the Analytical Development (AD) team and providing onsite training and assay transfer support at the CDMO for Sana’s cell therapy programs. You will be an essential business partner with Technical Operations and will support Sana’s analytical control strategy and bring Sana’s pipeline to patients across the world.
The location for this position is onsite in Philadelphia, PA.
What you’ll do
- Act as a primary analytical liaison between Sana’s internal technical functions and the CDMO for drug substances and cellular drug products to ensure success of assay tech transfer activities from Sana to the CDMO
- Partner with Sana’s internal technical functions to align on assay transfer strategies and coordinate with the CDMO to provide onsite training and support AD as Person-in-Plant (PiP)
- Monitor assay transfer activities and report on CDMO’s performance against project plans and timelines
- Identifies, notifies, and/or escalates risks and issues that may impact program timelines, resource requirements, finances, or business relationships
- Executes strategies that drive effective operational performance and service levels at contract organizations
- Effectively communicates project, performance, and resource issues to management and within project teams
- Ensure CDMO delivers to support Sana’s business needs, including flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's Quality expectations
What we’re looking for
- PhD in Cell Biology, Molecular Biology, Immunology, or a related scientific discipline with 2+ years of industry experience. BA and/or MS plus 7+ years or equivalent combination of education and work experience
- Technical expertise in the following areas: multi-color flow cytometry assays and cell-based assays for potency
- Hands-on experience with using the following analytical instruments: BD FACSLyric, Beckman Coulter CytoFLEX, and Miltenyi MACSQuant flow cytometers; MESO QuickPlex MSD instrument; and Bio-Rad QX200 ddPCR system
- Experience in transferring assays from internal AD to QC teams and/or externally to a CDMO
- Experience in performing phase-appropriate assay qualification/validation in a GLP or GMP environment
- Knowledge and understanding of regulatory guidelines from the FDA, ICH, USP, EP, etc.
- Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external stakeholders
- Proven ability to problem solve, build strong relationships, and to organize effectively
- Results-oriented and demonstrated focus on achieving business results. Experience with project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders
- Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
- High degree of self-motivation
- Ability to quickly adapt to changing business conditions
What will separate you from the crowd
- Technical expertise in viral titer assays and molecular assays utilizing ddPCR and/or qPCR
- Prior experience working with cell and gene therapy CDMOs for early to pivotal phase products or in a tech transfer role
What you should know
- Working in BSL-2 and BSL-2+ labs is required
- Occasional weekend work is required
- Up to 50% travel is required
- The base pay range for this position at commencement of employment is expected to be between $130,000 and $160,000/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
- 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.