Director, Biosample Operations Manager

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 Director, Biosample Operations Manager will be responsible for ensuring robust and efficient sample shipment, sample testing and data reporting. You will report to the SVP of Development Operations and be a member of the Development Operations group and play an essential role in organizing complex clinical sample management processes across multiple clinical programs. Areas of responsibility include coordination between the central biorepository lab, CROs, all groups within Sana collecting clinical samples, clinical operations and clinical data management, as well as alignment of clinical sample management activities with individual program and corporate goals.  Cool stuff.

What you’ll do

• Will be the point of contact and functional lead for all operational activities relating to vendor and sample management plans in order to deliver quality samples used in clinical studies
• Serve as the on-going operational point of contact between clinical study team, CRO, central and testing labs for communication regarding sample logistics and availability, batching and testing timelines, reanalysis, and data reporting
• Interface and collaborate with Clinical operations, Biomarker lead, Central lab, specialty labs, other Sana functions as necessary and CRO to generate the Lab Manual and Flow Chart
• Support Clinical Data Management on generation of Biomarker Assay Data Transfer documents
• Oversee shipping and receipt of patient samples from central labs to assay laboratories. Provide sample shipment and analysis metrics and status updates to product development teams
• Oversight of the tracking of budget and timelines for clinical testing labs and communication with internal stakeholders on tracking
• Identify sample discrepancies and missing samples, request queries, track queries and assist in query resolution. Identify stakeholders for questions impacting analysis and custody of samples and escalates issues to internal and external parties to ensure a timely resolution
• Maintain sample and data repository. Support sample analysis data transfer, data reconciliation and data review
• Responsible for data handling/archiving at the completion of the study and coordinating archiving of clinical samples with all groups at Sana collecting clinical samples
• Work with clinical team to review and set up clinical documents, and ensure all stakeholders are involved for the review
• Help create efficient sample flow in partnership with all departments collecting clinical samples at Sana

What we’re looking for

• Bachelor's is required, an advanced degree a plus. 8+ years of related experience with previous clinical biosample management and clinical laboratory vendor management is preferred
• Strong organizational skills with attention to details. Independently manage multiple competing priorities, while working on multiple projects simultaneously
• Ability to simplify complex processes
• Ability to work across multiple departments
• Knowledge and proficiency in FDA & ICH/GCP regulations and guidelines

What will separate you from the crowd

• Previous cell and/or gene therapy experience

What you should know

• Occasional travel required
• 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
• The base pay range for this position at commencement of employment is expected to be between $190,000 and $225,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
• 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.  Details of participation in these benefit plans will be provided if a candidate receives an offer of employment

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.

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.