Associate Director, Purification Process Development
Evotec
4 hours ago
On-site
Redmond, WA
Operations
What You’ll Do
- Lead a purification department covering purification process development, characterization, validation, and technology transfer to cGMP manufacturing for hybrid and end-to-end continuous processes.
- Lead highly complex projects and investigations using deep purification process development knowledge and broad knowledge across multiple functional areas.
- Collaborate across the organization to accelerate clinical development timelines while reducing development costs.
- Drive technology development for process intensification and continuous manufacturing to reduce manufacturing cost and footprint (culture productivity, product quality control, and data management) with vendors/external partners and influence the biologics industry.
- Serve as Project Team Lead on client projects involving multiple functional areas and full regulatory stages.
- Act as an internal technical resource for cGMP manufacturing and Process Design; serve as a purification SME for external clients/partners (small scale models, process transfer, scale up) and author CMC regulatory sections.
- Communicate scientific information, experimental plans, and data to internal/external stakeholders including regulatory agencies, review boards, and scientific conferences.
- Manage staff, training, capital resources, and planning; support multiple client projects at various development stages.
- Other tasks as assigned.
Who You Are (Qualifications)
- BS/MS in Engineering, Biochemistry, Biology, or related field with 15+ years’ experience OR Ph.D. with 9+ years’ experience.
- Expertise in continuous purification technology development, cGMP transfer, and authoring CMC sections.
- Experience with commercial process development, process characterization, and validation.
- Expertise in DOE and statistical analysis.
- Experience training/mentoring/supervising teams; leading purification development teams for external and internal initiatives.
- Plus: Experience with high throughput methods (e.g., HT assays, TECAN, Robo-Columns, lab automation).
Pluses
- Experience analyzing data in JMP, R, or Python.
- Experience in cGMP or clean room settings (non-GMP role; GMP knowledge helpful for tech/process transfer).
Compensation & Benefits (if included)
- Base pay range: $154,000–$174,000; plus discretionary annual bonus and benefits including Medical, Dental, Vision, disability, life insurance, 401k match, flexible work, paid time off/holidays, wellness, and transportation.
Application Instructions
- Apply today.
- Lead a purification department covering purification process development, characterization, validation, and technology transfer to cGMP manufacturing for hybrid and end-to-end continuous processes.
- Lead highly complex projects and investigations using deep purification process development knowledge and broad knowledge across multiple functional areas.
- Collaborate across the organization to accelerate clinical development timelines while reducing development costs.
- Drive technology development for process intensification and continuous manufacturing to reduce manufacturing cost and footprint (culture productivity, product quality control, and data management) with vendors/external partners and influence the biologics industry.
- Serve as Project Team Lead on client projects involving multiple functional areas and full regulatory stages.
- Act as an internal technical resource for cGMP manufacturing and Process Design; serve as a purification SME for external clients/partners (small scale models, process transfer, scale up) and author CMC regulatory sections.
- Communicate scientific information, experimental plans, and data to internal/external stakeholders including regulatory agencies, review boards, and scientific conferences.
- Manage staff, training, capital resources, and planning; support multiple client projects at various development stages.
- Other tasks as assigned.
Who You Are (Qualifications)
- BS/MS in Engineering, Biochemistry, Biology, or related field with 15+ years’ experience OR Ph.D. with 9+ years’ experience.
- Expertise in continuous purification technology development, cGMP transfer, and authoring CMC sections.
- Experience with commercial process development, process characterization, and validation.
- Expertise in DOE and statistical analysis.
- Experience training/mentoring/supervising teams; leading purification development teams for external and internal initiatives.
- Plus: Experience with high throughput methods (e.g., HT assays, TECAN, Robo-Columns, lab automation).
Pluses
- Experience analyzing data in JMP, R, or Python.
- Experience in cGMP or clean room settings (non-GMP role; GMP knowledge helpful for tech/process transfer).
Compensation & Benefits (if included)
- Base pay range: $154,000–$174,000; plus discretionary annual bonus and benefits including Medical, Dental, Vision, disability, life insurance, 401k match, flexible work, paid time off/holidays, wellness, and transportation.
Application Instructions
- Apply today.