Associate Scientist / Manufacturing Engineer
About The Position
Transpire Bio is seeking a highly motivated Associate Scientist / Manufacturing Engineer to join the Formulation and Process Development Team. The role supports development, scale-up, technology transfer, and validation of sterile liquid formulations for drug-device combination products. The position supports formulation and process development across laboratory studies, process characterization, manufacturing scale-up, aseptic manufacturing, technology transfer, and process validation. The successful candidate will work 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. The role offers hands-on experience in developing and manufacturing inhalation therapies in a dynamic, fast-paced environment.
Requirements
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
- 2–5 years of experience in a technical, manufacturing, operations support, process development, formulation development, or engineering role within the pharmaceutical, biotechnology, or medical device industry.
- 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.
Nice To Haves
- A minimum of 3 years in a technical or operations support role is preferred.
- Experience supporting aseptic processing, sterile filling, or pharmaceutical manufacturing operations.
- 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.
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 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
