What’s it like to work for Bend BioScience?
We are building a company with the talent, culture and tools to transform and lead the CDMO industry though innovation. The best part is…we’re doing it in a stellar location with all the best activities: Bend, Oregon. Never heard of it? Do a google, you’ll like it.
Do you:
• Often find yourself getting caught up (read: nerd out) in discussions on science & technology?
• Like finding new and better ways to do things?
• Want to help develop medicines to make patients’ lives better?
• Desire to always be learning and growing?
• Authentically and meaningfully value people?
• Desire to be audacious, entrepreneurial and to take calculated risks selected with a trusted and capable
team?
• Value Safety (personal and environmental) and leading by example?
• Care about “doing the right thing” even when it’s not the easy path?
At Bend Bioscience, we are looking for colleagues with: SCIENTIFIC CURIOSITY, HONESTY, HUMOR, CONFIDENCE, HUMILITY, TRUSTWORHTYNESS, RESPECT FOR CO-WORKERS, and the DESIRE TO MAKE A DIFFERENCE/HELP PATIENTS.
Job Description:
Bend BioScience is focused on research, development, and clinical production of non-sterile drug products and
intermediates for the pharmaceutical industry. As a start-up, this position will be instrumental in defining a quality culture and building systems, policies, and procedures to define a compliant organization with quality instilled throughout all operational aspects. The individual will need to be able to apply their regulatory and quality experience to GMP requirements for investigational new medicines for use in the US and Europe.
The Director of Quality Assurance works collaboratively with other departments to execute with high quality standards and mitigate and resolve potential quality issues by:
• Provide leadership and guidance on quality to operations and technical functions for a dynamic early phase clinical focused CDMO organization focused on investigational new medicines
• Develop, implement, and administer QMS software system
• Lead the review and approve investigations, incidents, CAPAs, and laboratory investigation reports
• Lead and manage the GMP training program
• Lead and manage supplier and material qualifications
• Provide leadership and point-of-contact in regulatory and client audits
• Ensure organizational compliance with regulatory guidelines, company policies, procedures, work instructions, and training requirements.
• Represent Bend Bioscience quality and regulatory policy to the clients
• Support quality and regulatory aspects of client programs.
• Collaborate with clients and suppliers on quality, regulatory, and technical issues
• Drive site specific continuous improvement of the Bend Bioscience Quality System
• Ensures Bend Bioscience is following cGMP guidelines and ensures the staff Is following Bend Bioscience Quality policies and SOPs.
• Thorough understanding of GMP Regulations (FDA, EU, JP) and specific regulatory guidance, applicable to early phase clinical requirements and the production of investigational new medicines
• Proficiency in MS Office applications; Word, Excel, Outlook
• Strong organizational skills
• Strong oral and written communication skills
Work Experience Requirements
• Minimum 10 years of experience in the pharmaceutical industry, including a minimum of 7 years of QA experience.
• Experience in drug product manufacturing and CDMO space preferred.
Education Requirements
• Minimum Bachelor’s Degree in Science