VP - Analytical Development
- Location: California
- Working situation: Hybrid
- Level: Vice President
As the VP - Analytical Development, you will be part of a large pharmaceutical manufacturing company with the intermediate and active pharmaceutical ingredient manufacturing operations team. You will manage the analytical strategy ensuring quality, compliance, and innovation.
The VP - Analytical Development will lead a team of analytical QC scientists, by providing expertise in drug substance & drug product analytical development for small molecules, from all stages of the drug development cycle with a special focus on early-stage development. Your expertise will drive the successful progression of drug development programs, making a significant difference on patients' lives worldwide.
The VP - Analytical Development will:
- Create and implement a visionary analytical development strategy that aligns with mission and goals, bringing our client closer to transforming the biotechnology industry
- Design and execute strategies for phase-appropriate development in the drug lifecycle, including analytical comparability, stability, and regulatory submissions
- Use their expertise in tech-transfer and assay qualification/validation campaigns as well as regulatory (pre)IND support
- Be able to oversee bio-focused methods including molecular biology, PCR, ELISA, & assay development as well as chemistry-focused methods including method development, validation, HPLC, LCMS, & GC
- Lead cross-functional project teams to drive and execute CMC development plans, ensuring timely delivery and alignment with business objectives
- Collaborate with cross-functional teams to support cGMP manufacturing, ensuring compliance with regulatory standards and best practices
The VP - Analytical Development has the following qualifications:
- 6+ years experience with small molecules
- 8+ years of experience in contributing to CMC efforts from Phase I to Phase III (desired)
- Bachelor's Degree with 12+ years of experience, OR Master's Degree with 10+ years of experience, OR Ph.D. with 10+ years of industry experience
- Competitive 401K program, health insurance, and HSA accounts
- Long term incentives in the terms of equity or stock at this level
- Hybrid role
If you have a passion for small molecules and thrive in leadership roles, we invite you to grab this opportunity! Join us on this transformative journey by applying today.