Principal Scientist, Commercial and Late-Stage Purification Process Development
$159,000–$207,000 year
On-siteSouth San Francisco, California, United States
Job Summary
Lead downstream purification technical activities for commercial and late-stage process development, including continued process verification, deviation support, and cross-site alignment. Design, oversee, and interpret small-scale process development studies to inform large-scale manufacturing decisions while building and maintaining technical risk assessments and process history files. Manage lifecycle activities such as tech transfer validation, regulatory filing updates, and responses to health authority questions. Drive technical continuity across CDMO and internal sites by ensuring consistent application of lessons learned and process understanding.
Required Qualifications
- PhD in Biology, Biochemistry, Chemical Engineering, or a related scientific discipline
- 10+ years of related work experience
- Strong experience with commercial process support and technology transfers
- Strong experience with downstream purification process characterization
- Strong experience with process validation
- Experience managing post-approval changes as a technical SME in collaboration with site, regulatory, supply chain and quality
- Experience reviewing batch records
- Experience supporting deviation investigations
- Experience assessing process performance during manufacturing campaigns
- Proven track record of representing bioprocess functions in cross-functional teams
- Proven track record of working effectively with CDMOs
- Broad experience in process characterization
- Broad experience in design of experiments
- Broad experience in analytics
- Experience developing downstream purification processes to support early- or late-stage clinical production
- Expertise in AKTA protein purification systems
- Expertise in antibody characterization methods
- Expertise in other biophysical techniques
- Excellent critical thinking
- Excellent scientific problem-solving
- Excellent communication skills
Desired Qualifications
- Familiarity with BLA authoring
- Familiarity with post-approval regulatory support
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