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.