Overview In this role you drive R&D activities for new product development and life-cycle management of ASP products in collaboration with R&D and Operations. You'll work on biochemistry and microbiology initiatives, including BI production and microbial fermentation, to enable robust processes and compliant product launches. You will partner with cross-functional teams to integrate manufacturing processes and support CAPA, NPI, and change management. This position combines hands-on science with process improvement to protect patient safety and support ASP's mission.
Compensation / Benefits Responsibilities- Support NPD and BI production development and sustaining activities in biochemistry and microbiology
- Assist microbial fermentation development and commercialization
- Contribute to design changes for marketed products, including validations and supplier process robustness
- Collaborate with manufacturing engineers to integrate product processes and systems
- Apply Six Sigma/Lean tools to drive new product introductions and process improvements
- Support life cycle management for consumable medical device products and related CAPA investigations
- Support CIP, NPI, and change management projects for product lines focusing on microbiology
- Communicate business issues to management and escalate opportunities as needed
- Execute product development and validation in support of production commercialization for medical device reprocessing and infection control
- Ensure compliance with ISO, FDA guidance, and prepare documentation demonstrating compliance
- Perform other duties as needed
Key requirements- Bachelor's degree in Microbiology, Biochemistry, Biomedical Engineering or related field with 3-5 years of experience, or an MS in Microbiology with 0-2 years of applicable experience
- At least 2 years in Medical Device or other GxP-regulated industry
- At least 2 years of product development or manufacturing experience (technical operations, transfer, or assurance)
- Familiarity with IQ/OQ/PQ and PV processes preferred
- Experience in microbial fermentation preferred
- Knowledge of analytical techniques, method development, validation, and transfer
- Self-driven, innovative mindset with strong problem-solving skills and ability to work independently or in a team
- Effective verbal and written communication for cross-functional teams
- self-motivated
- strong problem-solving
- cross-functional collaboration
- biochemistry and microbiology expertise
- microbial fermentation
- analytical method development, validation, transfer
