Scientist II, Biopharmaceuticals (CE, HPLC)

Thermo Fisher Scientific•Middleton, WI

5d•Onsite

About The Position

The Scientist II works in a multifunctional GMP laboratory supporting drug development and collaborating with cross-functional teams. The role uses analytical instrumentation and laboratory procedures to measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing. The position is fully onsite in Middleton, Wisconsin. Applicants may be based 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 background check that includes drug screening. The Scientist trains on analytical instrumentation, standard operating procedures, and regulatory requirements; conducts routine to complex sample preparation and analysis with minimal supervision; and independently manages quality-control responsibilities, equipment troubleshooting, and specified quality-assurance tasks. The role includes accurate laboratory documentation, review of results against SOP acceptance criteria, project-status communication, authoring lower-complexity quality records, and participation in investigations. The position requires a bachelor's degree in a laboratory science such as chemistry or biochemistry, or a similar field, and comparable experience of two or more years.

Requirements

Bachelor's degree in a laboratory science such as chemistry, biochemistry, or a similar field.
Comparable experience of 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 work collaboratively and demonstrate behaviors aligned with Thermo Fisher's 4i Values.
Legally authorized to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
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.

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 to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing.
Complete laboratory documentation clearly and accurately according to 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.