Senior Manufacturing Scientist - Production

About the Role

The Senior Manufacturing Scientist is responsible for identifying, investigating, and resolving complex technical issues associated with current products while qualifying enhancements to existing products. This role plays a critical part in ensuring robust, compliant manufacturing processes and supporting both existing products and new product introductions. The role partners closely with Manufacturing, Quality, R&D, and Supply Chain teams and supports both ongoing manufacturing operations and strategic technical initiatives.

Responsibilities

• Lead complex technical projects including product and site transfers, failure investigations/root cause analysis, and design changes and product enhancements.
• Support validation activities related to: Process improvements, process characterization and optimization, and transfer of new products from development into commercial manufacturing.
• Apply rigorous scientific problem-solving methods to resolve complex technical issues, utilizing structured investigation, hypothesis testing, and data-driven decision-making.
• Provide day-to-day manufacturing support, offering scientific and technical expertise to maintain robust manufacturing processes, investigate manufacturing failures and excursions, and ensure processes perform consistently within defined specifications and parameters.
• Design and execute experiments using advanced Design of Experiments (DoE) methodologies.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biological Sciences, Chemical Engineering, or related field and 5+ years of experience or Master’s degree and 3+ years of experience or PhD.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).
• Strong written and verbal communication skills, with the ability to clearly present data, influence decisions, and constructively debate technical topics.
• Ability to travel as needed for projects – 10% travel.

Preferred Skills

• Industrial experience within a regulated environment (e.g., medical devices, diagnostics, pharmaceuticals, biotechnology).
• Hands-on technical experience with Design of Experiments (DoE), statistical analysis and data interpretation.
• Biological or chemical product/process optimization.