Staff Scientist

Staff Scientist

The Staff Scientist is responsible for R&D life cycle management (LCM) activities and projects pertaining to biological indicator (BI) products; lead new and sustaining product related projects for ASP products in support of the company's strategic plan.

Under general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, the primary responsibilities of this position will be to perform or direct the execution of the following activities:

• Lead liquid culture for microbial fermentation process development and implementation
• Collaborate on the studies for enzyme purification and activity control with biochemistry SME
• Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects
• Lead R&D and life cycle management activities; provide guidance to other scientists as needed
• Lead design changes for marketed products such as manufacturing steps, process, or design validations, product testing, marketing analysis ensuring robust processes that meet CTQs
• Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems
• Lead or support and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principals and procedures
• Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology (e.g., biological indicator)
• Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements
• Prepare and assist of strategic vision or plan by collaborating with other cross functional departments
• Communicate business related issues to management timely
• Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents from such as ISO, QSR or FDA, and in preparation of documentation demonstrating compliance
• Perform other duties assigned as needed

Minimum experience and education for this position is a bachelor's degree in a scientific discipline, such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field, and 7-9 years of applicable experience, or a master's degree with 5-7 years of applicable experience, or a PhD with 2-4 years of applicable experience

• At least 7 years of experience in the Medical Device or other GxP-regulated industry preferred
• At least 5 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred
• Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred
• Professional experience and understanding of QSR, FDA, and ISO guidelines preferred

• Fermentation on microbial liquid culture and its upstream and downstream process experience are strongly preferred
• Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferred
• Capability to develop study protocols, analyze data, and propose theoretical solutions/explanations for sterilization or biological indicator manufacturing studies (e.g., D-value, stability testing). Sound statistical analysis is required (i.e., Minitab, etc.);
  Provide guidance and supervisory role to microbiology associates conducting hands-on testing for Biological Indicator manufacturing (e.g., titers, D-value, stability testing) or sterilization (e.g., D-value and cycle validation)
• Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred
• Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, quality engineering, etc.)
• Knowledge AAMI/ISO standards in the area of biological indicators and/or terminal sterilization
• Demonstrated experience in process development and/or validation preferred
• Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferred
• Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred
• The successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a team
• Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment
• This person may supervise or train junior scientists
• Collaborate with Quality Assurance, Supply Chain, and…