Role OverviewThe (Associate) Director of Drug Product will lead work with various vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Travel to vendors both domestically and internationally might occasionally be required.
What You Will Do
Manage and guide external vendors, execute physiochemical characterization and pre-formulation studies, design and develop nonclinical formulations, support clinical formulation development, and represent CMC at internal and external cross-functional team meetings.
Why It Might Be a Fit
The successful candidate will have a demonstrated track record of designing high-performance nonclinical and clinical formulations, managing CROs and CDMOs, and developing and manufacturing nonclinical and clinical small molecule drug products to support Phase I to Phase III.
Requirements
- BS or MS in Pharmaceutical Sciences or a related scientific discipline required; PhD strongly preferred
- 10+ years of experience in small molecule formulation development
- Deep understanding of formulation development and manufacturing of poorly soluble (BCS Class II/IV) small molecule compounds
- Strong knowledge of pharmaceutical and engineering principles related to liquid and solid dosage form development
- Proficiency with analytical and solid-state characterization techniques
- Experience managing external development partners (CROs, CDMOs, CMOs)
- Working knowledge of cGMP requirements and pharmaceutical development standards
Benefits
- Annual base salary range: $170,000.00 to $195,000.00
- Discretionary annual bonus
- Comprehensive benefits package
- 401(k) plan
- Company-sponsored medical, dental, vision, and life insurance
- Generous paid time off
- Health and wellness program
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