Senior Scientist, Purification Process Development

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 147,000 - 191,000; Full time

Benefits offered by this job

401k

Healthcare coverage

Employee Stock Purchase Plan

Job summary

Denali Therapeutics Inc. in South San Francisco invites you to contribute to our large molecule pipeline by leading purification/downstream process characterization and related late-stage activities.

You will author protocols, coordinate studies, review results, and draft IND/BLA sections to support regulatory filings. Ideal candidates hold a PhD in Biology/ Biochemistry/ Chemical Engineering with 5+ years in purification development, possess hands-on AKTA/HPLC/LC-MS expertise, and demonstrate

Qualifications

• PhD in Biology, Biochemistry, Chemical Engineering or related discipline with 5+ years purification development experience.
• Experience with purification process characterization and validation is required.
• Experience reviewing batch records and PPQ campaigns.
• Familiarity with BLA authoring is preferred.
• Proven track record representing bioprocess functions in cross-functional teams with CMOs.

Responsibilities

• Lead purification/downstream process characterization, tech transfer, and late-stage activities.
• Author protocols, coordinate study execution, review analytical results, generate reports, and author IND/BLA sections.
• Coordinate internal teams to generate late-stage process characterization and/or validation data packages.
• Support selection/coordination of CMOs to generate high-quality late-stage data packages.
• Transfer purification processes to CMOs and support ongoing manufacturing activities.
• Design and execute lab-scale chromatography and filtration studies to inform large-scale decisions.
• Maintain workflows to provide purification support for cell line and cell culture development.
• Execute methods for in-process testing using ELISA, HPLC, UV and SDS-Page based analytics.

Skills

Purification development

Process characterization

Biotech industry experience

Cross-functional collaboration

Education

PhD in Biology/Biochemistry/Chemical Engineering

Tools

AKTA purification systems

HPLC

LC/MS

SDS-PAGE

DLS

Job description

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.This position is responsible for characterizing/validating purification processes and authoring IND/BLA sections to support our large molecule pipeline.

Key Accountabilities/ Core Job Responsibilities:

• Lead purification/downstream process characterization, tech transfer, and late-stage activities
• Author protocols, coordinate study execution, review analytical results, generate/review reports, and author IND/BLA sections
• Coordinate internal team to generate late-stage process characterization and/or validation data packages
• Support selection/coordination of CDMOs as needed to generate high-quality late-stage data packages
• Transfer purification processes to CMOs and support ongoing manufacturing activities as needed
• 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 plus a minimum of 5+ years of purification development experience in the biotech/biopharma industry.
• Experience with purification process characterization and validation is required.
• Experience reviewing batch records and familiarity with Process Performance Qualification (PPQ) campaigns.
• Familiarity with BLA authoring is preferred.
• Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs.
• Broad experience in process characterization, design of experiments and analytics.
• Experience developing protein purification processes to support early or late-stage clinical production.
• Knowledge of process virology, including working with contract labs to plan and execute viral clearance studies, is desired.
• 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.

Compensation and Benefits:

• Salary Range: $147,000.00 to $191,000.00 .

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.

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.

“Life at Denali” is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.