What are the responsibilities and job description for the Director, Quality Control Lab position at Denali Therapeutics?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This position plays a key role in directing and managing all aspects of the laboratory, including personnel, equipment, and resources and compliance for both the microbiology and chemistry departments.
Key Accountabilities/Core Job Responsibilities
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This position plays a key role in directing and managing all aspects of the laboratory, including personnel, equipment, and resources and compliance for both the microbiology and chemistry departments.
Key Accountabilities/Core Job Responsibilities
- Lead and develop a team of analysts and their teams in their respective field of microbiology and analytical controls and compliance
- Oversight of all project-related quality control topics, development requirements and program milestones including reporting
- Oversee and manage core tasks for testing a) GMP review and control for quality control documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems
- Contribute to new product introduction and technology transfer for analytical and microbiology testing by collaborating with multiple functions within the organization.
- Maintain ownership of GMP and compliance activities for laboratory and always ensure inspection readiness.
- Contribute to overall functional direction for Denali Therapeutics for Quality Control for internal manufacturing site
- Research external benchmarks that help to aid superior performance of products, processes and people
- Implement and execute externalization activities with internal departments, facilitate development of execution plans for each, and ensure completion
- Manages complete line function responsibility for all departmental programs and initiatives
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
- BS in Chemistry, Microbiology or equivalent science
- 10 years of experience working in GMP regulated laboratory
- 8 years of people management.
- Demonstrates project oversight and leadership and cross-functional awareness to advance the quality control function
- Strong collaboration and project management skills
- Familiar with Master Control, LabWare LIMS and Kneat validated enterprise system
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
