Lead Analytical Chemist - Drug-Device Development, Pharmaceutical R&D

Ready to be the drug development expert building analytical capabilities from ground zero for breakthrough medical device technology?

Pave Talent is hiring on behalf of our client, an established mid-sized biotechnology company in the Gaithersburg biotech corridor known for their patient-centric mission, proven commercial success, and collaborative culture. With 20-30 employees and growing R&D operations, they're pioneering drug-eluting medical devices that address a devastating problem: 1-in-3 women who undergo breast reconstruction after cancer develop post-surgical infections requiring implant removal.

The Impact You'll Drive

As Lead Analytical Chemist, you'll solve product variability challenges currently bottlenecking development of technology that could change outcomes for millions of breast cancer survivors. Your HPLC troubleshooting, method development, and regulatory submissions will enable a 2-3 year pathway to market—dramatically faster than traditional pharmaceutical development. This isn't corporate bureaucracy—you'll be the first pharmaceutical expert in a medical device company, with direct influence over analytical strategy, CMC processes, and commercial launch timelines.

What You'll Do

🔬 Troubleshoot spray coating variability through hands-on HPLC method development, drug release assay optimization, and systematic problem-solving to accelerate development timelines (~50% of role)

🤝 Manage external CDMO/CRO analytical programs including method transfer, validation oversight, and regulatory compliance across contract laboratories (~50% of role)

📊 Author analytical sections for CDRH/CDER regulatory submissions, validation protocols, and FDA reviewer responses

👥 Build and eventually lead internal analytical team as company scales from R&D to commercial manufacturing

✅ Establish quality systems, define analytical best practices, and ensure ICH/FDA compliance as the company's only drug development expert

🎯 Collaborate with Chief Scientific Officer, VP R&D, and cross-functional teams to enable registrational submissions planned for next year

What You Bring

Required:

- 10+ years pharmaceutical analytical chemistry with small molecules (not biologics—this distinction is critical)

- Expert HPLC/UPLC troubleshooting with recent hands-on experience personally running instruments and solving method development challenges

- Proven CDMO/CRO management including method transfer, vendor oversight, and quality coordination

- Working knowledge of ICH guidelines and FDA guidance for method validation and pharmaceutical development

- Startup or small company experience building capabilities with limited resources

- BS/MS in Chemistry or Pharmaceutical Science (PhD with 6+ years or MS/BS with 12+ years)

Preferred:

- Drug-device combination product or drug-eluting medical device experience

- Mass spectrometry and spectroscopic techniques expertise

- PMA submission experience with CDRH regulatory pathway

- CMC tech transfer and manufacturing support background

The Reality: First 12-18 Months

Let's be direct—this is a builder's role, not a manager's role initially. You'll spend half your time hands-on at the bench running HPLC, troubleshooting split peaks and variability, developing drug release assays. The other half managing CDMOs remotely. No direct reports for 12-18 months while establishing the analytical foundation. Current infrastructure: one Waters HPLC, basic spectroscopy equipment, with dissolution setup arriving soon. Most validation work contracted externally.

If you're looking for an established analytical department with full infrastructure and immediate team leadership, this isn't it. But if you're energized by defining best practices from scratch, having direct influence on company direction, and building something meaningful—this is a rare ground-zero opportunity.

Why This Opportunity Stands Out

💰 Competitive compensation for analytical chemistry expertise in DMV market with comprehensive benefits and equity potential

🚀 Fully funded for 3+ years from successful product sale to Boston Scientific—no layoff risk from fundraising pressure

🎯 Medical device regulatory pathway (CDRH) enables 2-3 year product launch vs. 8+ pharmaceutical timelines with lower costs and no Phase 1/2/3 trials

🧠 Be the only drug development expert educating leadership and owning entire drug-related testing strategy—your recommendations carry weight

👥 Direct exposure to VP R&D and Chief Scientific Officer on-site daily in small, tight-knit team (7-person R&D group)

🏗️ Build and lead analytical/QC function as company scales to commercial manufacturing—hire your team, purchase equipment, define systems

Work Environment

On-site position in Gaithersburg, Maryland with flexible start times (7am-3pm, 8:30am, or 10:30am works). Hands-on lab work required. Family-friendly culture with focus on results over face time. Fast-paced startup environment with funding security. Small collaborative team where everyone knows your name and values your contributions.

Ready to Make an Impact?

This is a confidential search. Your application is fully private. Apply via LinkedIn and Pave Talent will contact qualified candidates within 3-5 business days.