Senior Director Medical Writing

Found in: Jooble US O C2 - 2 weeks ago


Seattle WA, United States Sana Biotechnology Full time

About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As the Bothell Sr. Director Quality Control, you will report to the Executive Director, Site Quality Head, Technical Operations, to provide the Quality Control oversight on the facility startup, qualification and validation activities, and the routine analytical product and in-process controls at the site.
What you’ll do
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. Approve reports as per schedule
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
What we’re looking for
~ Familiarity with the US, EMA, and ICH regulations and guidance documents and USP, EP and JP
~ Good working knowledge of analytical and bioanalytical assays
~ Demonstrated ability to engage team members across diverse teams
~ Promote curiosity, scientific rigor, and excellent problem-solving skills
~ 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

What will separate you from the crowd
Cell and Gene Therapy product experience
Successful facility startup and regulatory inspection experience
Experience with flow cytometry, bioassays, molecular biological assays and microbiological assays
What you should know
Work may involve aseptic gowning for activities in the cleanroom
There may be potential exposure to BSL2 biohazardous materials that are handled in the laboratories
There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing
The role will be located in Seattle, WA until the Bothell manufacturing site is ready for occupancy
The base pay range for this position at commencement of employment is expected to be between $230,000 and $270,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
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