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 companys strategic plan.

Responsibilities

Under general direction and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines the primary responsibilities of this positionwill 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

Education

Minimum experience and education for this position is a bachelors 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 masters degree with 5-7 years of applicable experience or a PhD with 2-4 years of applicable experience

Related 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

Knowledge and Skills

• 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 Regulatory Affairs partners