What You’ll Do
- Design, develop, and scale purification processes across development stages (early development through commercial)
- Apply data-driven approaches (e.g., DoE) to characterize processes and define robust control strategies
- Lead or support technology transfer of processes into GMP manufacturing
- Troubleshoot process challenges and drive continuous improvement in process performance
- Collaborate with Manufacturing, Analytical, Quality, Non-Clinical, and Regulatory teams to enable program advancement
- Author technical reports and contribute to CMC sections of regulatory filings and respond to agency questions
Who You Are
- Hands-on purification scientist with strong analytical, statistical, and technical writing/communication skills; passionate about process development and able to present technical data and support regulatory documentation
Required Skills
- Ph.D. in chemical engineering, chemistry, or related science with 0–3 years of experience
- Master’s degree in chemical engineering, chemistry, or related science with 4+ years of experience in pharmaceutical or biotech settings
- Bachelor’s degree in chemical engineering, chemistry, or related science with 6+ years of relevant experience in pharmaceutical or biotech settings
- Experience in purification process development (preferably industrial)
- Strong analytical skills and statistical analysis expertise
- Proficiency in technical writing and presenting technical data
Preferred Skills
- Experience developing processes for oligonucleotides, peptides, and/or proteins
- Familiarity with GMP manufacturing processes
- Collaborative mindset and experience in cross-functional teams
Benefits
- Medical, Dental, Vision, & Life insurances; fitness & wellness programs (fitness reimbursement); short- and long-term disability insurance; paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31); paid holidays and Personal Significance days; sick time; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation