Formulation Development Scientist

Job Description

Job Description

We are seeking a highly motivated Formulation Development Scientist to join a Formulation and Process Development team supporting the development, scale-up, technology transfer, and validation of sterile liquid formulations and drug-device combination products.

The Formulation Development Scientist will support formulation and process development activities spanning laboratory studies, process characterization, manufacturing scale-up, aseptic manufacturing support, technology transfer, and process validation. The position provides hands-on experience in pharmaceutical formulation development, process development, aseptic manufacturing, and the development of inhalation and combination products within a fast-paced R&D environment.

Employment Type: Contract

Location: Coral Spring, Florida

Department: Research & Development

Compensation: $32–$37/hour

Schedule: 1st Shift: 7:00 AM–5:00 PM or 2nd Shift: 4:00 PM–2:00 AM

Key Responsibilities

• Execute formulation and process development studies for sterile liquid and inhalation drug products.
• Support formulation preparation, mixing, sterile filtration, aseptic filling, inspection, and packaging operations.
• Optimize and scale manufacturing processes from laboratory and pilot scale to manufacturing scale.
• Conduct laboratory, pilot-scale, and manufacturing studies to evaluate process performance, product quality, and process robustness.
• Collect, analyze, and interpret experimental and manufacturing data to support technical decisions and process improvements.
• Support process characterization and Design of Experiments (DOE) activities.
• Support technology transfer from development activities into clinical and commercial manufacturing.
• Assist with engineering batches, process validation, PPQ activities, and continued process verification.
• Provide technical support to manufacturing operations and assist with real-time troubleshooting of process issues.
• Support investigations, deviations, CAPAs, change controls, and root-cause analysis.
• Support the development and integration of inhalation drug-device combination products.
• Support evaluation of primary packaging and container closure systems.
• Prepare and review technical documentation, including protocols, reports, manufacturing instructions, risk assessments, and development summaries.
• Collaborate with internal cross-functional teams and external partners to support development and commercialization activities.
• Maintain compliance with cGMP requirements, safety procedures, quality systems, and applicable regulations.
• Participate in continuous improvement and operational excellence initiatives.

Minimum Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific or engineering discipline.
• 2–5 years of relevant experience in formulation development, process development, manufacturing, technical operations, engineering, or operations support within the pharmaceutical, biotechnology, medical device, or related industry.
• Experience with sterile process manufacturing and/or pharmaceutical formulation development.
• Working knowledge of pharmaceutical manufacturing processes and cGMP requirements.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Experience analyzing technical data and preparing technical reports.
• Strong written and verbal communication skills.
• Ability to work effectively in a collaborative, cross-functional environment.
• Ability to work hands-on in laboratory, pilot-scale, and manufacturing environments.

Key Skills & Competencies

• Pharmaceutical Formulation Development
• Sterile Liquid Formulation
• Process Development
• Manufacturing Scale-Up
• Aseptic Processing
• Sterile Manufacturing
• Technology Transfer
• Process Validation
• Process Characterization
• Inhalation Drug Product Development
• Drug-Device Combination Products
• Data Analysis
• Experimental Design and Execution
• DOE and Statistical Analysis
• Technical Troubleshooting
• Root Cause Analysis
• cGMP Compliance
• Technical Documentation
• Technical Writing
• Cross-Functional Collaboration
• Continuous Improvement

Qualifications

• Experience with aseptic processing, sterile filling, or pharmaceutical manufacturing operations.
• Experience with inhalation, respiratory, or combination drug products.
• Experience with formulation development and process characterization.
• Familiarity with DOE and statistical analysis tools.
• Experience supporting investigations, CAPAs, deviations, risk assessments, and validation activities.
• Knowledge of FDA, EMA, ICH, USP, and combination product requirements.
• Familiarity with pharmaceutical manufacturing equipment and automated inspection systems.
• Experience working in cGMP laboratory, pilot-plant, or manufacturing environments.
• Experience supporting engineering, clinical, registration, or commercial manufacturing batches.
• Ability to stand, walk, bend, reach, and lift up to 50 pounds as required.