Executive Director, Manufacturing Site Start Up Lead

Location
South San Francisco, CA, United States
Posted
Jul 16, 2021
Ref
5388917002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

Sana is seeking a dynamic and experienced manufacturing leader to deliver the user requirements for our first GMP cell and gene therapy facility. This would include the on time and on budget realization of this strategic investment to enable pivotal production. Reporting to the Head of Manufacturing and Supply Chain, you will lead a cross functional team and represent the user voice for the detailed design through start-up of this capital investment. You will also take all measures to achieve or exceed the required GMP standards and perform qualification for enabling startup and commissioning. After commissioning, the program lead would potentially transition into the facility manufacturing operations head depending on the selected candidates experience and qualification as well as the success of this project.

DUTIES AND RESPONSIBILITIES
  • Key leader representing user of this facility (and other key stakeholders), together with the facilities lead and project manager to jointly direct all phases of this CapEx project from detailed design through project start-up (commissioning and qualification)
  • Provide technical leadership and management of the user team (comprising manufacturing, process and analytical development, validation, automation, maintenance, quality, IT, tech transfer, etc) responsible for project execution.
  • Actively partner with external vendors and consultants to incorporate best in class facility design and GMP requirements for a state-of-the-art ATMP facility
  • Responsible for evaluating and supporting selection of the key equipment to perform operations throughout the facility
  • Oversee first tech transfer of clinical product into this facility.
  • For commercial product, oversee the Process Performance qualification (PPQ), filing preparation and regulatory inspection readiness prior to full commercial operations.
  • Demonstrate Sana's core values and the attributes that support these core values (Lead from every seat, Thrive as a team, Make it happen)
  • Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
  • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
  • Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
  • Innate ability to assess talent that will help grow the organization and add Sana's culture

QUALIFICATIONS

Basic Qualifications
  • Bachelor of Science degree in Biological Sciences, Biomedical/Chemical Engineering, or Engineering; a combination of experience and advanced education in other disciplines may also be considered
  • Minimal 15+ years of biotech, cell or gene therapy, or pharmaceutical industry experience in manufacturing, process development process scale up/tech transfer and process validation
  • Experience with commercial scale manufacturing for cell culture, purification, aseptic final product filing and/or analytical reagent manufacture, current GMPs and FDA as well as EMA regulations
  • Experience with health authority regulatory inspections.
  • Strong Global Leader, motivating team player, drives results, excellent communication skills.
  • Capable of managing diverse stakeholders in multicultural environments.
  • Experienced in project management with demonstrated track record to lead through influencing
  • 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, subject to certain exceptions, be fully vaccinated against COVID-19

Preferred Qualifications
  • To qualify as the head of manufacturing of this facility, the candidate should have prior relevant experience in running the cGMP operations in the biotech or pharma industry


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job description listed above is representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

The Company is 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, 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.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short and long term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.