Formulation Development Scientist
7 days ago
Fort Lauderdale
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.