Scientist II, R&D

ICU Medical; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Scientist II for their R&D team in Austin, TX. The role specializes in method development, optimization, and validation, requiring a strong background in analytical chemistry. Candidates should have proven expertise in complex chemical analyses and the ability to guide and train junior analysts. This position offers a great opportunity for professional growth in a supportive and innovative environment.

Qualifications

• Experience with analytical instrumentation (3-4 years) is required.
• Capabilities in documenting experimental findings clearly.
• Knowledge in cGMP, SOP, and laboratory processes is necessary.

Responsibilities

• Perform method development, optimization, and validation for lab analyses.
• Support stability testing and analytical method verification.
• Train new analysts and troubleshoot instrument issues.

Skills

Method Development

Analytical Skills

Troubleshooting

Technical Writing

Time Management

Education

BS degree in Analytical Chemistry, Chemistry, Chemical Engineering, Polymer Chemistry, or Chemical Science

Job description

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Position Summary

The Scientist II performs method development, method optimization and test method validations/verifications, applies scientific principles, methods and techniques to troubleshoot chemical and instrumental analyses, optimizes current methods and processes, supports cross-functional teams, performs equipment validations, and identifies/leads laboratory projects.

• Perform complex chemical and instrumental analyses to support laboratory functions such as stability testing, in-process solutions, raw materials, commodities, blended resin, film and final product solutions in multiple laboratories.
• Performs analytical method development/optimization and/or verification/validation of analytical methods.
• Write and execute qualification/verification/validation/stability study protocols and write summary reports detailing study findings.
• Write, troubleshoot and/or modify analytical test methods, as required.
• Train new analysts in daily operations, workflow, and instrumental methods (both theory and practice).
• Investigate inconsistent results and propose possible causes and solutions, including documentation of the investigation via applicable laboratory investigation / exception report documentation.
• Perform preventive maintenance (PM). Troubleshoot and resolve all instrument problems in the laboratory.
• Work with vendors to evaluate instruments, and make decisions involving future instrument purchases based on needs and costs.
• Work with CQ Laboratory Technical Services on methods development, methods transfer studies, and cross check studies.
• Set daily and weekly short-term goals to ensure timely completion of projects.
• Adhere to cGMP's, SOP's, and plant policies/guidelines.
• Produce clear, consistent written documentation of data to support development studies, occasional routine testing, regulatory filings, or stability reports.
• Will be cross-trained to work in other laboratory areas as dictated by the needs of the organization.
• Coordinate the schedules and duties of the team in the supervisor’s absence.
• Perform other related duties as assigned or required.
• Assist site technical teams to troubleshoot analytical and solution chemistry issues.
  
  

Job Description

Scientist II, Research & Development

FLSA Status: Exempt

Position Summary

The Scientist II performs method development, method optimization and test method validations/verifications, applies scientific principles, methods and techniques to troubleshoot chemical and instrumental analyses, optimizes current methods and processes, supports cross-functional teams, performs equipment validations, and identifies/leads laboratory projects.

Essential Duties & Responsibilities

• Perform complex chemical and instrumental analyses to support laboratory functions such as stability testing, in-process solutions, raw materials, commodities, blended resin, film and final product solutions in multiple laboratories.
• Performs analytical method development/optimization and/or verification/validation of analytical methods.
• Write and execute qualification/verification/validation/stability study protocols and write summary reports detailing study findings.
• Write, troubleshoot and/or modify analytical test methods, as required.
• Train new analysts in daily operations, workflow, and instrumental methods (both theory and practice).
• Investigate inconsistent results and propose possible causes and solutions, including documentation of the investigation via applicable laboratory investigation / exception report documentation.
• Perform preventive maintenance (PM). Troubleshoot and resolve all instrument problems in the laboratory.
• Work with vendors to evaluate instruments, and make decisions involving future instrument purchases based on needs and costs.
• Work with CQ Laboratory Technical Services on methods development, methods transfer studies, and cross check studies.
• Set daily and weekly short-term goals to ensure timely completion of projects.
• Adhere to cGMP's, SOP's, and plant policies/guidelines.
• Produce clear, consistent written documentation of data to support development studies, occasional routine testing, regulatory filings, or stability reports.
• Will be cross-trained to work in other laboratory areas as dictated by the needs of the organization.
• Coordinate the schedules and duties of the team in the supervisor’s absence.
• Perform other related duties as assigned or required.
• Assist site technical teams to troubleshoot analytical and solution chemistry issues.
  
  

Knowledge, Skills & Qualifications

• Must be self-directed and have participated in and successfully completed projects, demonstrating good communication, writing skills, and organizational and time management skills.
• Must have familiarity with method development, verifications, validations, as well as USP and ICH guidelines.
• Must be able to provide general guidance to other analysts on a day-to-day basis.
• Must follow organized thought processes and have the visual acuity to accurately complete the extensive necessary documentation, plus a thorough understanding of the chemistry and theory involved.
• Must have technical writing capability and be familiar with verifications, validations and qualifications.
• Capable of operating complex instrumentation with limited supervision.
• Must be able to apply standard scientific principles, methods and techniques to trouble-shoot and resolve common analytical problems and technical service requests.
• Must be able to resolve routine analytical and quality problems with limited assistance and supervision.
• Position requires an understanding and capability of performing maintenance on laboratory instrumentation on a daily and monthly basis.
• Must be able to manipulate algebraic equations on a daily basis.
• Must be able to use mathematics to solve routine problems.
• Must be able to trouble-shoot and resolve a myriad of routine instrumental problems.
• Must be self-directed and demonstrate good organizational and time management skills.
• Must possess good communication and writing skills and be able to work effectively in cross-functional teams with all levels of individuals within the organization.
• Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality.
  
  

Education And Experience

• BS degree in Analytical Chemistry, Chemistry, Chemical Engineering, Polymer Chemistry, or Chemical Science (other science degrees will be considered)
• 3-4 years recent analytical instrumentation experience; or a BS degree in Biology with 5+ year’s recent analytical instrumentation experience. PhD in Chemistry/Biology with 2+ year’s recent analytical instrumentation experience. Thorough knowledge of the various instruments used in the lab, including: theory, preventive maintenance, troubleshooting and compendia terminology and requirements
  
  

Minimum Qualifications

• Must be at least 18 years of age
  
  

Travel Requirements

• Typically requires travel less than 5% of the time
  
  

Physical Requirements And Work Environment

• Office and laboratory environment. Frequent exposure to hazardous chemicals, the numerous methodologies that are required to test product, and the time constraints under which the work is accomplished.
• Ability to work night, weekend and holiday hours as required by projects and by support for 24/7 operation.
• Will be exposed to some incidental chemical fume exposure, typical of a chemistry laboratory environment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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