Thermo Fisher Scientific
Scientist III - Technical Project Manager
Thermo Fisher Scientific, West Middleton, Wisconsin, United States
Overview
Scientist III - Technical Project Manager This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our work spans laboratory, digital and decentralized clinical trial services as part of the PPD clinical research portfolio. Responsibilities
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. Independently performs and guides a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing. Completes all laboratory documentation in clear and accurate language according to SOP and GMPs. Independently troubleshoots equipment and instruments and mentors others in troubleshooting when applicable. Reviews and compiles results from assignments and makes initial determinations on acceptability per SOP acceptance criteria; navigates OOS/OOT/Atypical investigations and leads investigations and root cause analysis and CAPA proposals. Manages QC responsibilities, communicates project status to project leader, and helps identify gaps and anticipate roadblocks in project team workflow. Coordinates laboratory activities of other team members in conjunction with the lab supervisor; assists with study design and protocol authoring; leads data evaluation and study close-out. Independently completes QA-facing tasks and authors/ leads more complex quality records as needed. Qualifications
Education
Bachelor’s degree or equivalent and relevant formal academic/vocational qualification Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills, Abilities
Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines; ability to interpret SOP and regulatory guidelines during study design. Technical background on biopharmaceutical methods such as HPLC, CE, or ELISA strongly preferred. Ability to understand and independently apply GMPs to documentation and instrument use. Strong manual dexterity, written and verbal communication skills, and time/project management abilities. Proven problem-solving and troubleshooting abilities; ability to independently optimize analytical methods and cross-train on sample preparation techniques with another laboratory group. Thrive in a collaborative environment and demonstrate alignment with the company values. Work Environment
Able to communicate with diverse groups in a comprehensible manner. Able to work upright and stationary for typical working hours; able to lift and move objects up to 25 pounds. Able to work in non-traditional laboratory environments; may be exposed to potentially hazardous elements including infectious agents. Able to perform successfully under pressure while prioritizing multiple projects. Disclaimer: Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Scientist III - Technical Project Manager This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our work spans laboratory, digital and decentralized clinical trial services as part of the PPD clinical research portfolio. Responsibilities
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines. Independently performs and guides a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing. Completes all laboratory documentation in clear and accurate language according to SOP and GMPs. Independently troubleshoots equipment and instruments and mentors others in troubleshooting when applicable. Reviews and compiles results from assignments and makes initial determinations on acceptability per SOP acceptance criteria; navigates OOS/OOT/Atypical investigations and leads investigations and root cause analysis and CAPA proposals. Manages QC responsibilities, communicates project status to project leader, and helps identify gaps and anticipate roadblocks in project team workflow. Coordinates laboratory activities of other team members in conjunction with the lab supervisor; assists with study design and protocol authoring; leads data evaluation and study close-out. Independently completes QA-facing tasks and authors/ leads more complex quality records as needed. Qualifications
Education
Bachelor’s degree or equivalent and relevant formal academic/vocational qualification Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Knowledge, Skills, Abilities
Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines; ability to interpret SOP and regulatory guidelines during study design. Technical background on biopharmaceutical methods such as HPLC, CE, or ELISA strongly preferred. Ability to understand and independently apply GMPs to documentation and instrument use. Strong manual dexterity, written and verbal communication skills, and time/project management abilities. Proven problem-solving and troubleshooting abilities; ability to independently optimize analytical methods and cross-train on sample preparation techniques with another laboratory group. Thrive in a collaborative environment and demonstrate alignment with the company values. Work Environment
Able to communicate with diverse groups in a comprehensible manner. Able to work upright and stationary for typical working hours; able to lift and move objects up to 25 pounds. Able to work in non-traditional laboratory environments; may be exposed to potentially hazardous elements including infectious agents. Able to perform successfully under pressure while prioritizing multiple projects. Disclaimer: Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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