Senior Scientist, Purification Process Development

Denali Therapeutics

Denali Therapeutics

South San Francisco, CA, USA
Posted on Friday, August 25, 2023

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology, principles of translational medicine, and excellence in technical development.

The Opportunity

We are seeking to hire a Senior Scientist to join our Bioprocess Development team. The successful candidate will be responsible for leading tech transfer activities, supporting late stage PC/PV activities, and developing efficient, robust and scalable purification processes to support our large molecule pipeline.

Key Responsibilities

  • Design and execute lab-scale chromatography and filtration studies to inform and support large scale process decisions
  • Transfer early and late stage purification processes to CMOs and support ongoing manufacturing activities
  • Lead purification process characterization/validation activities and support PPQ runs
  • Author process descriptions, development reports, tech transfer documents and relevant IND/BLA sections
  • Work closely with discovery and other CMC functions to transfer process/molecule knowledge into development

Requirements

  • PhD in Biology, Biochemistry, Chemical Engineering, or related scientific discipline plus a minimum of 3+ years of purification development experience in the biotech/biopharma industry; MS with 8+ years of experience or BS with 10+ years of experience
  • Experience developing purification processes to support early and late stage clinical production including process characterization and validation activities
  • 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 analytics
  • Expertise in AKTA protein purification systems and antibody characterization methods including: HPLC, LC/MS, SDS‐PAGE, DLS and other biophysical techniques
  • Excellent critical thinking, scientific problem-solving and communication skills

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.

Salary Range: $142,000.00 to $183,000.00. 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.

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