What are the responsibilities and job description for the Lead Formulation Scientist position at Specialized Recruiting Group - Lakeland, FL?

Lead IV Formulation Scientist – Advanced Sterile Solutions (503B Outsourcing)

Location: Bartow, FL (Onsite at State-of-the-Art Manufacturing Campus)

About Assure Infusions

Assure Infusions is a leader in domestic IV fluid production, operating a robotics-driven 503B outsourcing facility dedicated to resolving critical shortages of premixed sodium chloride, lactated Ringer’s, and dextrose solutions. Our innovations directly support 92% of U.S. hospital IV therapy protocols. Join the newest and most advanced pharmaceutical fluid manufacturer in the country.

Your Impact

Design and scale life-saving IV therapies in a facility equipped with advanced automation and real-time analytics:

Solve stability challenges in pH-sensitive electrolyte buffer systems
Optimize 4,000L GMP batches for robotic filling lines (20M annual unit capacity)
Develop terminal sterilization protocols compliant with USP <797> Phase 3 standards
Lead cross-functional technical teams in process validation

Qualifications

Education

MS/PhD in Pharmaceutical Sciences, Chemical Engineering, or related field (Parenteral Specialization Preferred)

Experience

5 years formulating large-volume parenterals (LVPs) in 503B/cGMP environments
Proven success stabilizing dextrose solutions or electrolyte buffers at scale

Skills

Statistical process control (SPC) for formulation scaling
CTD documentation for ANDA/NDA submissions
FDA audit leadership in sterile processing

Compensation & Benefits

Salary: $95,000 – $125,000 base performance-based bonuses
Relocation Assistance (if needed)
Healthcare: Zero-premium medical/dental/vision plans for employee
Retirement: 401(k) with 6% company match
Growth: We actively promote and support bolstering your qualifications with continued education.
Lifestyle: PTO hybrid scheduling flexibility

Why Bartow?