Principal Scientist Commercial Late-Stage Purification Process Development
Overview
Lead downstream purification technical efforts for commercial manufacturing and late-stage process development at Denali Therapeutics. Drive process verification investigations and cross-site alignment while supporting lifecycle management activities for biologics. This role shapes technical strategy and ensures robust manufacturing outcomes.
What You'll Do11
- 1Serve as downstream purification technical lead for commercial manufacturing including continued process verification investigations and deviation support
- 2Support lifecycle management activities for commercial products through process improvements and tech transfer validation
- 3Drive technical continuity across CDMO and internal sites by capturing process understanding and lessons learned
- 4Design and oversee small-scale process development studies that inform large-scale manufacturing decisions
- 5Build and maintain technical risk assessments such as FMEAs and process history files for robust manufacturing
- 6Support incoming late-stage process development pipeline using platform knowledge and manufacturing experience
- 7Standardize lifecycle management practices for commercial programs
- 8Manage post-approval changes as a technical SME collaborating with site regulatory and quality teams
- 9Review batch records and assist deviation investigations during manufacturing campaigns
- 10Represent bioprocess functions in cross-functional teams and partner with CDMOs
- 11Develop downstream purification processes for early or late-stage clinical production
Requirements8
- 1PhD in Biology Biochemistry Chemical Engineering or related field with 10+ years of relevant experience
- 2Strong background in commercial process support and technology transfers
- 3Expertise in downstream purification process characterization and validation
- 4Proven experience managing post-approval changes as a technical SME
- 5Familiarity with AKTA protein purification systems and antibody characterization methods
- 6Ability to develop and apply process design of experiments and analytics
- 7Experience creating downstream purification processes for clinical production
- 8Knowledge of BLA authoring and regulatory support
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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