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.
Experiencewith 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, SDS0PAGE, DLS and other biophysical techniques
Excellent critical thinking, scientific problem-solving and communication skills
Salary Range: $147,000.00 to $191,000.00 . Compensation for the role will depend on a number of factors, including a candidate9s 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 Denali9s good faith estimate as of the date of publication and may be modified in the future.
