Sterile Formulation Scientist & Manufacturing Engineer

Valid8 Financial, Inc.; Town of Florida (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Transpire Bio is seeking an Associate Scientist / Manufacturing Engineer to join the Formulation and Process Development Team. You will support sterile liquid and inhalation product development, scale-up, and technology transfer from development through clinical and commercial manufacturing.

The role emphasizes collaboration across Formulations, Analytical Sciences, Operations, Quality, and Regulatory Affairs to build robust, compliant processes and enable biopharmaceutical product

Qualifications

• Bachelor's degree in a relevant engineering or sciences field.
• 2-5 years in technical/manufacturing roles within pharma/biotech/medical devices.
• Experience in sterile process manufacturing or pharmaceutical formulation development.
• Strong data analysis and technical reporting skills.
• Familiarity with cGMP requirements and quality systems.
• Strong written and verbal communication skills.
• Ability to work effectively in a collaborative, cross-functional environment.

Responsibilities

• Execute formulation and process development studies for sterile liquid and inhalation products.
• Support scale-up and technology transfer from development to manufacturing.
• Collaborate with QA, Regulatory, Operations and Analytical Sciences to ensure robust processes.
• Maintain compliance with cGMP and documentation practices.
• Provide troubleshooting and real-time technical support during manufacturing campaigns.
• 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.

Skills

Process Development

Aseptic Processing

Technology Transfer

Data Analysis

Cross-Functional Collaboration

Root cause analysis

Problem solving

Education

Bachelor's degree in Chemical/Biomedical/Mechanical Engineering or related

2-5 years in pharmaceutical/biotech/medical device manufacturing or process development

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Pharmaceutical Sciences

Bachelor's degree in Chemistry

Tools

DOE software

Statistical analysis tools

Automated inspection systems

Job description

Transpire Bio is seeking an Associate Scientist / Manufacturing Engineer to join the Formulation and Process Development Team. You will support sterile liquid and inhalation product development, scale-up, and technology transfer from development through clinical and commercial manufacturing.

The role emphasizes collaboration across Formulations, Analytical Sciences, Operations, Quality, and Regulatory Affairs to build robust, compliant processes and enable biopharmaceutical product