Senior Scientist, QC chemistry

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.

Reporting to the Senior Director of Quality, Salt Lake City, the Principal Scientist QC Chemistry will primarily develop, qualify and execute analytical test methods per both internal development and for a new large molecule drug substance manufacturing facility. This position supports establishing test methodology and testing of in-process and final drug substance and drug product samples.

Key Accountabilities/Core Job Responsibilities:

• Work with a team of scientists, cultivating growth and development.

• Participate in the troubleshooting and validation of core analytical methods.

• Collaborate with project teams to design, oversee and review relevant analytical methods, validation protocols and reports for programs across all phases of product lifecycle

• Drive continuous improvement initiatives related to phase-appropriate method development and validation practices within QC Laboratories

• Ensure the compliance and consistency of method execution and practices within the organization.

• Performs release and stability testing activities for drug substances and drug products

• Perform routine execution of QC samples, data review and approval.

• Assist with training of staff and development of organizational expertise on analytical methods and tech transfer activities for drug substances and product.

• Lead and/or participate as analytical subject matter expert in quality events such as OOS, LIR, Deviations, Change Controls and CAPA

• Conduct reference standard qualifications for drug substances and drug products

• Author and review analytical data, specifications, Certificate of Analysis, methods

validation protocols/reports, technical reports, and analytical CMC sections for IND and NDA filings, conduct data input, analysis, and interpretation

Qualifications/Skills:

• 7 or more years of Pharmaceutical or Biotech QC Chemistry

• BS in Biology / Chemistry or related life science

• Experience in biotechnology setting

• Experience in the space of method validation and transfer

• Experience in executing routine analytical testing

• Technical expertise on analytical techniques

• Technical expertise for troubleshooting, data review and interpretation

• Expertise on GMP concepts and practices

• Organizational and project management skills

• Communication skills both oral and written

• Knowledge and experience in writing/reviewing analytical reports for regulatory submissions

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at

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.