This position is responsible for driving downstream technical activities for commercial and late-stage process development for Denali's commercial and near-commercial biologics portfolio.
Key Accountabilities/Core Job Responsibilities:
- Serve as downstream purification technical lead for commercial manufacturing including continued process verification, investigations, deviation support, and cross-site alignment.
- Support lifecycle management activities for commercial products, including process improvements, tech transfer validation activities, local and cross-site change management, regulatory filing updates (CBE, PAS, Ex-US expansion), and responses to health authority questions.
- Drive technical continuity and alignment across CDMO and internal manufacturing sites by ensuring process understanding, lessons learned and technical decisions are consistently captured and applied.
- Design, oversee, and interpret small-scale process development studies that inform large-scale manufacturing decisions, support root-cause investigations, and enable lifecycle improvements.
- Build and maintain technical risk assessments (e.g., FMEA) and process history files to support robust commercial manufacturing and future late-stage programs.
- Support the incoming late-stage process development pipeline and commercial programs by applying best practices, platform knowledge, and prior manufacturing experience while contributing to standardization of lifecycle management practices.
Qualifications/Skills:
- Typically requires a PhD in Biology, Biochemistry, Chemical Engineering, or a related scientific discipline, plus 10+ years of related work experience.
- Strong experience with commercial process support and technology transfers, downstream purification process characterization, and process validation.
- Experience managing post-approval changes as a technical SME in collaboration with site, regulatory, supply chain and quality.
- Experience reviewing batch records, supporting deviation investigations, and assessing process performance during manufacturing campaigns.
- Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CDMOs.
- Broad experience in process characterization, design of experiments, and analytics.
- Experience developing downstream purification processes to support early- or late-stage clinical production.
- Expertise in AKTA protein purification systems, antibody characterization methods, and other biophysical techniques.
- Excellent critical thinking, scientific problem-solving, and communication skills
- Familiarity with BLA authoring and post-approval regulatory support is preferred.
Salary Range: $159,000.00 to $207,000.00 . 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.
