Senior Director
Quality Control
Posted on 3/22/2024
Sana Biotechnology

201-500 employees

Engineers cells as medicines for untreatable diseases
Company Overview
Sana Biotechnology, Inc. stands out as a leading company in the cell and gene therapy industry, with a unique focus on using engineered cells as medicines to treat diseases with poor outcomes or that are currently untreatable. Their competitive edge lies in their advanced delivery technologies, their ability to differentiate pluripotent stem cells into immune-cloaked functional cells, and their commitment to scalable manufacturing solutions. The company's culture is deeply rooted in impacting patients' lives, as evidenced by their ongoing development of diverse drug candidates aimed at broadening treatment possibilities.
Biotechnology

Company Stage

N/A

Total Funding

$865M

Founded

2018

Headquarters

Seattle, Washington

Growth & Insights
Headcount

6 month growth

-13%

1 year growth

-18%

2 year growth

-10%
Locations
Seattle, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Management
Data Analysis
CategoriesNew
Lab & Research
Life Sciences
Medical Research
Requirements
  • Familiarity with US, EMA, and ICH regulations and guidance documents
  • Good working knowledge of analytical and bioanalytical assays
  • Experience implementing Quality/Compliance systems
  • Collaboration skills
  • Experience with Project Management and Analytics software
  • BA or BS in life science or biochemistry degree
  • 12+ years' experience in the pharmaceutical or biotechnology industry in a Quality Control, Analytical Development, Quality or Compliance function managing department teams
Responsibilities
  • Provide Quality Control oversight for the facility startup, including qualification and validation activities
  • Build GMP quality systems and the compliance infrastructure for the Quality Control labs
  • Oversee lab instrument qualifications and test method transfers and qualifications
  • Establish and maintain analytical assay performance trending program and reference standard trending program
  • Oversee management of product and materials stability programs
  • Establish test reagent and materials inventory management process to ensure testing execution to planned schedules
  • Oversee equipment and instrument maintenance and calibration program to ensure testing execution to planned schedules
  • Manage the critical utilities monitoring program for the production facility and labs
  • Oversee material qualification program including materials risk assessments
  • Lead inspections by FDA, or other regulatory agencies for Quality Control topics
  • Serve as Business Process Owner for LIMS implementation
  • Manage to a high level of efficiency in lab execution by adopting strong interdepartmental communications and lean labs processes
  • Manage and mentor staff to ensure a high performing team
  • 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