Associate Director, External Manufacturing

Описание вакансии

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 an Associate Director, External Manufacturing you will report to the Executive Director, External Manufacturing to oversee day-to-day operational performance of key Sana contract development and manufacturing organizations (CDMOs). This will include coordinating and driving activities for pre-clinical and clinical phase drug substance (DS) and/or drug product (DP) manufacturing for Sana’s cell and gene therapy programs at 3rd party CDMOs. You will be an essential business partner within Technical Operations and will support Sana's manufacturing strategy to bring Sana's pipeline to patients across the world.

What you’ll do

• Acts as primary liaison and relationship manager between Sana Technical Operations and the CDMO to ensure timely delivery of high quality pre-clinical and clinical CGT product(s)
• Responsible for adherence to project schedule(s)
• Implement and execute governance structure with CDMO(s)
• Develops and oversees budget(s) for project(s) under their purview, including contributing to internal Sana budgeting activities and ensuring CDMO performance to financial plan in collaboration with Sana accounting.
• Partner with our technical departments to help ensure success of tech transfer activities from Sana to the CDMO partner.
• Monitors technical transfer and production campaign activities and reports on CDMOs performance against plans
• Identifies, notifies, and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationships
• Executes strategies that drive effective operational performance and service levels at contract organizations
• Negotiates and facilitates approval of contracts including proposals, master supply agreements, work orders, and changes of scope.
• Effectively communicates project, performance, and resource issues to management and within project teams
• Ensure CDMOs deliver to support Sana’s business needs including ensuring flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's quality expectations

What we’re looking for

• Bachelors degree with 5+ years plus of outsourced clinical and/or commercial manufacturing experience in the biotech/pharmaceutical industry
• Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment, including knowledge of cGMP quality systems
• Experience operating in early-stage clinical to commercial environments
• Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers.
• Proven ability to problem solve, build strong relationships, and to organize effectively
• Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
• 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

• Prior experience working with cell and gene therapy CDMOs

What you should know

• The base pay range for this position at commencement of employment is expected to be between $170,000 and $210,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
• Up to 25% travel (domestic and/or international)

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 workforce with varied backgrounds 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 a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample 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’sBenefits 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.