Zack D. Films is hiring a Scientist, Pharmaceutical Development to join our Analytical Sciences team. In this role, you will focus on stability programs and regulatory filings for our clinical-stage biopharmaceutical product candidates, ensuring key program milestones are met.
What You'll Do
- Build strong working relationships with Pharmaceutical Development functional leads, the Quality Assurance team, and third-party suppliers
- Support day-to-day management of contract laboratories performing analytical testing
- Oversee stability programs including data management, analysis, and trending
- Identify out of specification and out of trend results and guide investigations with contract organizations and internal teams
- Provide technical guidance during analytical method development and validation
- Author analytical CMC sections of regulatory filings to support clinical programs
- Appropriately escalate issues and risks to Senior Management and Pharmaceutical Development Leads
What We're Looking For
- Bachelor's degree or above in Pharmacy, Chemistry, or a related scientific discipline
- Minimum 4 years of relevant experience in a pharmaceutical development function, preferably analytical sciences
- Prior experience in the management of contract laboratories performing routine and non-routine testing, method development, and validation
- Strong working knowledge of cGxP requirements and relevant ICH and USP requirements
Nice to Have
- Working knowledge of JMP or other software for data trend analysis
- Solid oral drug product and/or drug substance analytical sciences experience
Benefits & Compensation
- Compensation range: $59,295.00 - $100,000.00 + equity
- 100% paid health benefits including Medical, Dental, and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks
