Senior Scientist, Purification Process Development

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 CMOsBroad 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

Salary Range: $ to $ . 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  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.