What are the responsibilities and job description for the Specialist, 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 will play a key role in managing, improving and streamlining the QC Laboratory operations for both 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 will play a key role in managing, improving and streamlining the QC Laboratory operations for both microbiology and chemistry departments.
Key Accountabilities/Core Job Responsibilities
- Schedule, manage and report status on routine and stability testing for drug substance and drug product for both Microbiology and Analytical Departments.
- Manage coordination with Facilities/Engineering and Vendor on site preventative maintenance, calibrations and work orders for analytical equipment/instruments and laboratory equipment
- Manage validation and revalidation of laboratory analytical equipment as department owner.
- Own system administration for all analytical equipment and LabWare LIMS.
- Ensure laboratory supplies, consumables, reagents, solutions are purchased and available for execution of test methods by analysts.
- Coordinate small and large projects for the Microbiology and Analytical Departments such as technology transfers, establishing stability program and supportive testing
- Coordinate QC analysts priorities with testing schedule
- Maintain the laboratories in an inspection readiness state
- Works with accuracy, urgency and a continuous improvement perspective
- Provide flexible support for on-call or outside normal business hours if required
- BS in Chemistry or equivalent science experience
- 3 years of experience working in GMP regulated analytical and chemistry laboratories
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Ability to work with independently
- Build productive relationships with internal teams and external sources
- Well-developed verbal and written communication skills
- Excellence in execution through accuracy, right first time and a proactive nature
- Physical requirements– must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
- Strong collaboration and project management skills
- Familiar with Master Control, LabWare LIMS and Kneat validated enterprise systems
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.
