Scientist II, Biopharmaceuticals (GMP)
About The Position
The Scientist II works in a multifunctional GMP laboratory environment supporting drug development and collaborating with cross-functional teams. The role uses innovation, partnership, creative problem-solving, and modern technology to perform pharmaceutical and biopharmaceutical stability and analytical testing. This is a fully onsite position at the GMP Laboratory in Middleton, Wisconsin. Applicants may be located anywhere in the United States, but relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. The Scientist performs routine to complex sample preparation and analysis with minimal supervision, quantitatively measuring compounds in formulations and biological matrices. The role includes independent quality-control responsibilities, instrument troubleshooting, accurate laboratory documentation, review of results, and quality-assurance-facing work. The Scientist also communicates project status, helps identify workflow gaps and roadblocks, authors low-complexity quality records, and participates in investigations.
Requirements
- Bachelor's degree in laboratory sciences, such as chemistry, biochemistry, or a similar field.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years.
- Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
- Knowledge of applicable regulatory authorities, compendia, and ICH guidelines.
- Excellent manual dexterity for precise and accurate work.
- Strong written and oral communication skills.
- Strong time-management and project-management skills.
- Problem-solving and troubleshooting abilities.
- Ability to communicate, receive, and understand information and ideas with diverse groups of people.
- Ability to work upright and stationary and/or standing for typical working hours.
- Ability to lift and move objects up to 25 pounds.
- Ability to work in non-traditional work environments and use and learn standard office equipment and technology.
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- Legally authorized to work in the United States without sponsorship.
- Ability to pass a comprehensive background check, including drug screening.
Responsibilities
- Train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
- Perform routine to complex sample preparation and analysis with minimal supervision or guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
- Complete laboratory documentation clearly and accurately in accordance with SOPs and GLPs.
- Independently troubleshoot equipment and instruments and mentor others in troubleshooting when applicable.
- Review and compile results from assignments and make initial determinations of acceptability according to SOP acceptance criteria.
- Perform work accurately, safely, and in a timely manner.
- Independently manage quality-control responsibilities.
- Communicate project status to the project leader and help identify gaps and anticipate roadblocks in project-team workflow.
- Complete quality-assurance-facing tasks with minimal supervisor or QA input.
- Author low-complexity quality records and participate in OOS/OOT/atypical investigations.
- Collaborate with cross-functional teams and cross-train on sample-preparation techniques with another laboratory group.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
