Position Summary
Transpire Bio is seeking a highly motivated Associate Scientist / Manufacturing Engineer to join the Formulation and Process Development Team supporting the development, scale-up, technology transfer and validation of sterile liquid formulations as applied to drug-device combination products.
This role will support formulation and process development activities spanning laboratory studies, process characterization, manufacturing scale-up, aseptic manufacturing support, technology transfer, and process validation. The successful candidate will partner closely with Formulations, Analytical Sciences, Operations, Quality, QC Microbiology, and Regulatory Affairs to develop robust, scalable, and compliant manufacturing processes for sterile liquid and inhalation products.
This position offers the opportunity to gain hands-on experience in development and manufacture of innovative inhalation therapies in a dynamic and fast-paced environment.
Key Responsibilities
- Execute formulation and process development studies for sterile liquid and inhalation drug products.
- Support optimization and scale-up of manufacturing processes, including formulation preparation, mixing, sterile filtration, aseptic filling, inspection, and packaging operations.
- Conduct laboratory and manufacturing studies to evaluate process performance, product quality, and process robustness.
- Collect, analyze, and interpret experimental and manufacturing data to support process improvements and technical decision-making.
- Support technology transfer activities from development through clinical and commercial manufacturing.
- Assist with engineering batches, process validation, PPQ activities, and continued process verification programs.
- Provide day-to-day technical support for manufacturing operations, including troubleshooting process issues and supporting investigations, deviations, CAPAs, and change controls.
- Support development and integration of inhalation drug-device combination products, including primary packaging and container closure systems.
- Author and review technical documents including protocols, reports, manufacturing instructions, risk assessments, and development summaries.
- Collaborate with internal teams and external partners to support project execution and commercialization activities.
- Maintain compliance with cGMP requirements, safety procedures, and company policies.
Minimum Qualifications
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
- 2-5 years of experience in technical, manufacturing, operations support, process development, formulation development, or engineering role within the pharmaceutical, biotechnology, or medical device industry.
- Minimum 3 years in a technical or operations support role preferred.
- Experience in sterile process manufacturing and/or pharmaceutical formulation development.
- Working knowledge of pharmaceutical manufacturing processes and cGMP requirements.
- Strong analytical, troubleshooting, and problem-solving skills.
- Experience analyzing technical data and generating technical reports.
- Strong written and verbal communication skills.
- Ability to work effectively in a collaborative, cross-functional environment.
Key Skills & Competencies
- Sterile Liquid Formulation Development
- Process Development and Manufacturing Scale-Up
- Aseptic Processing and Sterile Manufacturing
- Technology Transfer and Process Validation
- Inhalation Drug Product Development
- Drug-Device Combination Products
- Data Analysis and Experimental Execution
- Technical Problem Solving and Root Cause Analysis
- cGMP Compliance and Documentation
- Technical Writing and Communication
- Cross-Functional Collaboration
- Continuous Improvement and Operational Excellence
Preferred Qualifications
- Experience supporting aseptic processing, sterile filling, or pharmaceutical manufacturing operations is highly preferred.
- Experience with inhalation, respiratory, or combination drug products.
- Familiarity with process characterization, DOE studies, and statistical analysis tools.
- Experience supporting investigations, CAPAs, risk assessments, and validation activities.
- Knowledge of FDA, EMA, ICH, USP, and combination product regulations.
- Familiarity with pharmaceutical manufacturing equipment and automated inspection systems.
Working Conditions
- Full-time onsite position located in a laboratory, pilot plant, and cGMP manufacturing environment.
- Routine work in classified cleanroom environments requiring gowning and adherence to aseptic processing and contamination control practices.
- Hands-on operation of laboratory, pilot-scale, and manufacturing equipment used for formulation development, sterile filtration, aseptic filling, inspection, and packaging.
- Frequent interaction with cross-functional teams during manufacturing campaigns, development studies, technology transfer, and validation activities.
- Ability to stand, walk, bend, reach, and lift up to 50 pounds as required to support laboratory and manufacturing operations.
- May be required to work in controlled manufacturing areas for extended periods while supporting engineering, clinical, registration, and commercial batches.
- Ability to provide real-time technical support for manufacturing operations, troubleshooting activities, investigations, and process improvement initiatives.