Scientist I

Duties And Responsibilities

Under supervision of manager or senior scientists, and general direction, and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:

• Support projects, activities, and applications related to principles of biochemistry and microbiology from R&D, operations, and QA with focuses on development and improvement of procedures for NPD and sustaining biological indicator (BI) production
• Biochemical and Microbiological activities include analyses of enzymes, liquid culture for BI production, and analytes from cultivation, production, and application of microorganisms
• Assist microbial fermentation development and commercialization
• Responsible for R&D laboratories of bioreactor and biofilm facilities and associated equipment operations, safety, and maintenance
• Conduct qualitative and quantitative microbiological and chemistry analysis of raw materials and finished goods. Executes experiments, makes observations, calculates and records results, documents experimental data and completes required documentation
• Support design changes for marketed products such as manufacturing steps, process or design validations, product testing, etc.
• Assist life cycle management activities for capital and consumable medical device products as well as any associated NC or CAPA investigations
• Be responsible for communicating business related issues or opportunities to next management level
• Performs other duties assigned as needed

Other Duties

• Assist R&D and life cycle management activities, such as test method validation and transfer
• Provide supports to other programs and project teams as needed
• Meet and follow Good Documentation Practice
• Plan and perform basic reliability testing and analysis

Education

Minimum experience and education for this position is a Bachelor's degree in a scientific discipline, such as Biochemistry, Bioengineering, Microbiology, or a closely related field

Years Of Related Experience

• 0 – 2 years in a Microbiology laboratory or related environment
• 0 – 2 years with IQ/OQ/PQ and PV processes and microbial fermentation experience preferred

Knowledge, Skills, Abilities, Certifications/Licenses, And Affiliations

• Understanding of compliance with applicable laboratory and safety procedure
• The successful candidate must be self-driven, innovative, and capable of working 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