Senior Process Engineer – Advanced Drug Delivery Platform
Location: Greater Boston Area
An innovative biotechnology company developing next-generation drug delivery technologies is seeking a Senior Process Engineer to support development and scale-up of novel therapeutic manufacturing processes. This organization is focused on advancing transformative delivery platforms designed to improve accessibility, stability, and patient outcomes across a range of therapeutic applications.
Position Summary
The Senior Process Engineer will play a key role in process development, manufacturing scale-up, and continuous improvement initiatives supporting clinical and future commercial manufacturing operations. This individual will work cross-functionally with engineering, manufacturing, quality, and product development teams in a fast-paced, highly collaborative environment.
Responsibilities
- Design, execute, and analyze process development experiments to optimize manufacturing unit operations
- Characterize and improve manufacturing processes through data analysis and experimental modeling
- Support manufacturing scale-up activities through assessment of equipment, workflows, analytical methods, and process configurations
- Implement process and equipment improvements within GMP manufacturing operations
- Revise and maintain batch records, SOPs, work instructions, and other controlled documentation
- Support quality system and GMP compliance activities
- Collaborate closely with cross-functional technical and operational teams
- Mentor junior engineers and technical personnel, including oversight of direct reports
Qualifications
- BS or advanced degree in Engineering (Mechanical, Biomedical, Manufacturing, Materials Science, or related field)
- 7+ years of hands-on engineering experience within medical device, biotechnology, pharmaceutical, or combination product industries
- Experience supporting process development and manufacturing operations in GMP-regulated environments
- Strong background in experimental design, data analysis, and process optimization
- Experience with statistical methodologies such as DoE, Six Sigma, or multivariate analysis preferred
- Excellent communication, project management, and problem-solving skills
- Ability to thrive in a fast-paced, entrepreneurial, team-oriented environment
Preferred Experience
- Combination products or advanced drug delivery systems
- Manufacturing scale-up and technology transfer
- Process analytical technologies (PAT)
- Automated manufacturing equipment and systems
