Happy Money is hiring a Scientist for Pharmaceutical Development. You will support pharmaceutical development activities, including managing contract labs, overseeing stability programs, and authoring regulatory filings. This position is part of a patient-centric company with a continuously expanding global footprint.
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 to ensure key program milestones are met.
- Oversee stability programs including data management, analysis, and trending.
- Identify out of specification and out of trend results and collaborate with contract organizations and internal Pharmaceutical Development and Quality Assurance teams to guide investigations.
- Provide technical guidance during analytical method development and validation.
- Author analytical CMC sections of regulatory filings to support on-going and future 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 working 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.
Technical Stack
- JMP
Team & Environment
You will work with Pharmaceutical Development functional leads, the Quality Assurance team, and third-party suppliers, reporting to the Pharmaceutical Development Leads.
Benefits & Compensation
- Compensation range: $59,295.00 - $100,000.00 + equity: Employees in this role may be entitled to equity.
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents.
- 401(k) program with company match and vesting after the turn of the first month after your start date.
- Flexible time off.
- Generous parental leave.
- Some fun fringe perks.
Work Mode
This position is remote.
Happy Money is an equal opportunity employer.
