Job description

Position: Associate Director, Quality Assurance

Location: Seattle, WA (Onsite or Remote)

Blaze Bioscience, Inc. Is a privately held biotechnology company dedicated to improving the lives of cancer patients, starting with kids undergoing brain cancer surgery. By leveraging our Tumor Paint technology®, including the CANVAS Imaging system® and our CDP Discovery Platform, our goal is to make the detection, removal, and treatment of all cancers sensitive, reliable, and accessible, especially early-stage cancers where cure may still be possible.

We are seeking an experienced Quality Assurance Associate Director with knowledge of regulations, standards and guidelines related to the Chemistry, Manufacturing and Controls (CMC) of drug product and drug substances. The Associate Director is a key contributor on Blaze Bioscience’s Quality team and will contribute to Quality Management efforts that ensure compliance with applicable regulatory requirements and standards.

This position’s primary responsibilities & accountabilities:

• This individual will collaborate and partner closely with the CMC organization and Contract Manufacturers (CMOs) to ensure day-to-day activities maintain compliance under all applicable regulations
• Provide Quality Assurance support throughout the product lifecycle including drug development and manufacturing
• Provide Quality Assurance support to regulatory submissions
• Oversee Contract Manufacturers (CMOs) to assess process and product quality including performing batch record review, technology transfer review, validation document review, change notifications, and review of specifications
• Assist in Deviation, OOS/OOT, Nonconformance and CAPA investigations
• Participate in change management activities including development of justifications and impact of changes
• Collect and analyze Quality Management System key quality and performance data
• Review documents and records for completeness and compliance

Candidates should have relevant skills, education, and experience, including:

• BS degree in chemistry, biochemistry, or similar discipline with 8+ years of experience in pharmaceutical or biopharmaceutical quality assurance (Required); 10+ years of experience (Preferred)
• Knowledge of Peptide manufacturing
• Knowledge of Sterile fill/finish
• Knowledge of Stability programs
• Knowledge of Analytical data
• Strong technical writing skills
• Knowledge of pharmaceutical Quality Management Systems
• Experience with electronic document control systems
• Exceptional organizational and communication skills
• Team player

Work Location: This position may be performed remotely or in our Seattle office. Employee will need to come to the Seattle office periodically for meetings. Consequently, strong preference will be given to candidates who reside in Washington State.

COVID-19 Vaccination Requirement

Blaze Bioscience requires that all employees be fully vaccinated against COVID-19 unless a medical or religious exemption is approved. Newly hired employees will be required to provide proof of their COVID-19 vaccination as a condition of employment.

Blaze Bioscience, Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

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