Scientist I

The Scientist I, R&D Biochemistry and Microbiology (B&M), primarily supports projects for new product development (NPD), and assists life cycle management (LCM) activities, with sustaining product related projects for ASP products in alignment of company’s strategic plan under the leaderships of both R&D and Operations in close collaboration with the cross-functional manufacturing team.

Duties and Responsibilities

Under supervision of manger 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:

(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

• 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

Compliance

All employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures.

This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.