The Application Scientist will help develop and conduct qualitative and quantitative chemical analysis and experiments using the appropriate equipment and analytical techniques for medical device testing. The individual will perform a variety of analytical tests, prepare samples/standards/reagents, troubleshoot, maintain and run instruments. The position will also include techniques such as solvent exchange, concentration or dilution; standards and reagent preparation as needed to support laboratory operations. Additionally, this position is responsible for processing samples for assigned tests in compliance with GMP, ISO, and other standards including test sample log in and accountability. The position also includes the ordering and receiving of supplies and reagents used by the laboratory as well as setting up a functional process from sample and supply receiving, to storing and processing in the laboratory.

• Receives incoming samples and reviews them for integrity to ensure they are sufficient for testing.
• Disposition samples following testing completion, per client instruction and WuXi AppTec policies, including packing and shipping samples.
• Coordinates time and resources to ensure efficient processing of incoming projects.
• Review projects to ensure paperwork is complete and accurate.
• Serves as client point of contact for clarification and questions that arise during the sample receipt process.
• Initiates and maintains chain of custody of samples.
• Responsible for the ordering and receiving of laboratory supplies and reagents.
• Works with outside vendors as needed to mitigate any order/receiving issues with management help as required.
• Launches and assists in nonconforming material investigations.
• Uses laboratory inventory management system to maintain chain of custody of laboratory supplies and reagents.
• Independently perform routine and non-routine analysis on various instrumentation, such as HPLC/-MS, GC/-MS, IPC-MS, FT-IR.
• Perform advanced instrument maintenance and troubleshooting; investigate and facilitate the solving of any instrument failures.
• Create, review, and revise standard operating procedures (SOPs).
• Developing, documenting and carrying out method validations.
• Preparation of sample preparation protocols.
• Perform job specific tasks in compliance with applicable regulations, international standards, and WuXi AppTec policies and SOPs.
• Initiate and write laboratory investigations or deviations, assessing root cause and implementing appropriate corrective actions.
• Determine opportunities to increase efficiency and implement process improvements.
• Work in a team environment and independently as required.
• May train or mentor junior staff members.
• Responsible for clean and well-organized laboratory area.
• Provide assistance as needed for sample preparation and extraction.
• Provide assistance as needed for solvent exchange, concentration or dilution of samples; standards and reagent preparation.
• Prepares and implements deviations, laboratory investigations and CAPAs as needed
• Participates in various tasks including method design, development, validation and analysis.
• Performs custom protocols and validations within operational area and write final reports to support these activities.
• May be required to work holidays, overtime and/or outside of normal office hours/days as business needs and work volumes increase.
• May be required to assist in other departments
• Other duties as assigned

Experience / Education

• Technical assistant in chemistry or university degree in chemistry (BSc/MSc) with a strong background in chemical analysis
• 2+ years of relevant experience in a regulated environment
• Has demonstrated consistent performance on applicable instruments
• Extended knowledge of modern chemical analysis

Knowledge / Skills / Abilities:

• Read, write, speak and understand English is required and German is a plus
• Strong working knowledge in a regulated environment
• HPLC/-MS, GC/-MS, IPC-MS, IC, FT-IR experience is required
• Strong documentation skills
• Analytical method development and validation experience preferred
• Proven to be self-motivated and has strong initiative skills
• Detail oriented and independently driven
• Demonstrated strong troubleshooting and time management skills
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in a lab setting with exposure to biohazards/hazardous chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with minimal noise levels
• Ability to stand for long periods of time
• Clarity of vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to lift 25 lbs occasionally
• Ability to crouch, bend, twist and reach
• Inside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.