Senior Scientist, Purification Process Development

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

Benefits offered by this job

401k

Health coverage

ESPP

Job summary

Denali-Therapeutics is seeking a purification development scientist to lead upstream/downstream characterization and tech transfer for our large molecule programs.

You will author IND/BLA sections, coordinate study execution, review analytical results, and guide late-stage data packages. The role requires collaboration with internal teams and CMOs to ensure robust, validated purification processes for clinical production.

Qualifications

• PhD in Biology, Biochemistry, Chemical Engineering or related scientific discipline plus a minimum of 5+ years of purification development experience in biotech/biopharma.
• 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.
• 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 and working with contract labs for 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.

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.
• 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.

Skills

Purification development

Process characterization

Design of experiments

Cross-functional collaboration

CMO coordination

Protein purification analytics

HPLC/LC-MS/DSD techniques

Critical thinking

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 activitiesAuthor protocols, coordinate study execution, review analytical results, generate/review reports, and author IND/BLA sectionsCoordinate internal team to generate late-stage process characterization and/or validation data packagesSupport selection/coordination of CDMOs as needed to generate high-quality late-stage data packagesTransfer purification processes to CMOs and support ongoing manufacturing activities as neededSupport 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 decisionsMaintain existing workflows to provide purification support for cell line and cell culture development activitiesExecute methods for in-process testing using ELISA, HPLC, UV and SDS-Page based analyticsQualifications/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) campaignsFamiliarity with BLA authoring is preferred.Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOsBroad experience in process characterization, design of experiments and analyticsExperience developing protein purification processes to support early or late-stage clinical productionKnowledge of process virology, including working with contract labs to plan and execute viral clearance studies, is desiredExpertise in AKTA protein purification systems and antibody characterization methods including: HPLC, LC/MS, SDS‐PAGE, DLS and other biophysical techniquesExcellent critical thinking, scientific problem-solving and communication skillsSalary 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/careersThis 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.