Scientist, Late-Stage Purification Process Development

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 are seeking to hire a Scientist to join our Purification Process Development team. The successful candidate will be responsible for supporting characterization/validation of purification processes and authoring IND/BLA sections to support our large molecule pipeline.

Key Accountabilities/ Core Job Responsibilities:

• Support purification/downstream process characterization, validation, late-stage/commercial activities.

• Draft protocols, support study execution, review analytical results, generate/review reports, and support IND/BLA section authoring.

• Analyze commercial batch data and support concurrent validation studies.

• Propose and support late-stage or commercial process changes to improve process consistency/performance in collaboration with the site, quality and regulatory functions.

• Support tech transfer for clinical and PPQ campaign readiness.

• Review work from CDMOs as needed to produce high-quality late-stage deliverables.

• Support other late-stage projects and apply lessons learned to current projects.

• Design and execute lab-scale chromatography and filtration studies to inform and support large scale process decisions.

• Maintain existing workflows to provide purification support for cell line and cell culture development activities.

• Execute methods for in-process testing using ELISA, HPLC, UV and SDS-Page based analytics.

Qualifications/Skills:

• PhD in Biology, Biochemistry, Chemical Engineering, or related scientific discipline with some relevant late-stage purification process development experience in academia/industry or BS/MS with 5+ years of industry experience

• Experience with purification process characterization or validation.

• Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns.

• Familiarity with BLA authoring or commercial process support is preferred.

• Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs.

• Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies is desired

• Broad experience in protein characterization, design of experiments and analytical techniques

• Expertise in AKTA protein purification, tangential and normal flow filter sizing

• Excellent critical thinking, scientific problem-solving and communication skills

Salary Range: $125,000.00 to $158,000.00 . 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 https://www.denalitherapeutics.com/careers

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.