The Senior Application Scientist is primarily responsible for designing, developing, validating, and conducting complex qualitative and quantitative chemical analyses and experiments using LCMS, HPLC, GCMS, HS-GCMS, and other chromatography/spectroscopy instrumentation as needed. The individual will troubleshoot, maintain, run instruments and will lead, oversee, and execute R&D experiments to address regulatory gaps and solve compliance issues.

• Lead client education efforts, provide technical input in study design, assist in client regulatory submissions, evaluate and close method gaps per ISO 10993-18, write goals or designs for goals.
• Lead various tasks, including extractable/leachable studies, chromatography method development, feasibility, and validation.
• Evaluate the scientific technical portions of reports and raw data produced by peers.
• Identify gaps in methods and determine opportunities to implement process improvements while increasing efficiency.
• Support training and mentoring laboratory staff.
• Perform instrument maintenance and troubleshooting; investigate and facilitate the resolution of any instrument failures.
• Ensures the routine testing of client samples and reporting of results is accomplished in a timely and accurate manner.
• Oversee and execute protocols and write final reports to support these activities.
• Develop and write protocols and SOPs with little to no assistance.
• Initiate and write laboratory investigations or deviations, assessing root cause analyses and implementing appropriate corrective actions.
• Participates in regulatory compliance activities (i.e., audits and inspections) and technical interaction with clients.
• May be required to assist with environmental monitoring service questions outside of normal office hours/days.
• Other duties as assigned including assisting in other departments.
• May occasionally be required to work on holidays and overtime.

Experience / Education

• Minimum of 5 years relevant experience with a Masters
• Minimum of 3 years relevant industry experience with a PhD

Knowledge / Skills / Abilities:

• Expert chromatography and spectrometry skills (including tandem mass spectrometry)
• Expert knowledge of ISO 10993-12 and 10993-18
• Analytical method validation experience
• Method development experience
• Evidence of ability to lead cross-functional collaborations
• Ability to perform complex mathematical calculations
• Demonstrated chemistry preparation skills
• Proficient in oral & written communication
• Need to be able to read, write and understand English, German is a plus
• Proficient in Microsoft (Excel, Word, Outlook)
• Lab experience within a regulated environment preferred

Physical Requirements:

• Must be able to work in a lab setting with hazardous chemicals/biohazards
• 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, able to distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to lift 25 lbs occasionally
• Ability to crouch, bend, twist and reach

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.